{ "summary": { "structure": { "blank": { "controls": 803, "tables": 32, "paragraphs": 1963, "chars": 45299 }, "chatgpt": { "controls": 803, "tables": 32, "paragraphs": 1838, "chars": 89645 } }, "states": { "answered": 507, "not_in_csr": 295 }, "silent_fields_with_field_terms_on_some_csr_page": 0, "not_in_csr_fields_with_field_terms_on_some_csr_page": 259, "answered": 507, "answers_with_bracketed_csr_cites_in_field_text": 471, "sentence_page_checks": { "checked": 57, "cited_page_is_best_match": 22, "within_2_pages": 3, "off_by_more_than_2": 32 }, "numbers": { "on_cited_page": 744, "elsewhere": 70 }, "numbers_not_in_csr_examples": [], "cross_run_ui_vs_api_batched": { "answered|missing": 507, "not_in_csr|missing": 295 }, "groups": { "Long-term extension": { "answered": 3, "not_in_csr": 110 }, "Key efficacy outcomes": { "answered": 48, "not_in_csr": 37 }, "Other-design study": { "not_in_csr": 3, "answered": 71 }, "Systematic review": { "answered": 58 }, "Indirect comparison": { "answered": 54, "not_in_csr": 1 }, "Patient disposition": { "answered": 48, "not_in_csr": 2 }, "Estimated prevalence": { "not_in_csr": 42 }, "Efficacy outcome sample": { "answered": 21, "not_in_csr": 19 }, "Included studies": { "answered": 38 }, "Patient exposure": { "answered": 20, "not_in_csr": 4 }, "Subsequent treatment": { "answered": 21, "not_in_csr": 3 }, "Baseline characteristics": { "answered": 23 }, "Economic evaluation": { "answered": 4, "not_in_csr": 16 }, "Comparators": { "answered": 8, "not_in_csr": 6 }, "Statistical analysis": { "answered": 14 }, "Reimbursement conditions": { "not_in_csr": 13 }, "Analysis populations": { "answered": 12 }, "Summary of outcomes": { "answered": 8 }, "Inclusion criteria": { "answered": 7 }, "Long-term": { "answered": 3, "not_in_csr": 3 }, "Place in therapy": { "not_in_csr": 4, "answered": 1 }, "Review protocol PICO": { "not_in_csr": 2, "answered": 3 }, "Drug under review": { "answered": 3, "not_in_csr": 1 }, "Evidence gaps": { "answered": 3 }, "Other-design results": { "answered": 3 }, "Disease background": { "answered": 1, "not_in_csr": 1 }, "Diagnosis": { "answered": 1, "not_in_csr": 1 }, "Health Care Resources": { "not_in_csr": 2 }, "Literature search methods": { "not_in_csr": 2 }, "Excluded studies": { "not_in_csr": 2 }, "List of Tables": { "answered": 1 }, "List of figures": { "not_in_csr": 1 }, "Abbreviations": { "answered": 1 }, "Sponsor name": { "answered": 1 }, "Health Canada indication": { "not_in_csr": 1 }, "Health Canada approval status": { "not_in_csr": 1 }, "Health Canada review pathway": { "not_in_csr": 1 }, "NOC date": { "not_in_csr": 1 }, "Mechanism of action": { "answered": 1 }, "Recommended dosage": { "answered": 1 } } }, "rows": [ { "id": "666065098", "alias": "List of Tables", "group": "List of Tables", "state": "answered", "chars": 1091, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Tables in document order (original captions retained):1. Submitted for Review | 2. presenting the estimated prevalence in each region3. Key characteristics of Drug 1, Drug 2, etc. | 4. Proposed Reimbursement Conditions for the Drug Under Review5. Inclusion criteria for the systematic review | 6. Details of Included Studies7. Outcomes Relevant to the Systematic Review | 8. Statistical Analysis of Efficacy Endpoints9. Analysis Populations | 10. Baseline Characteristics11. Patient Disposition | 12. Patient Exposure13. Subsequent Treatment | 14. key efficacy outcomes15. efficacy outc" }, { "id": "880393120", "alias": "List of figures", "group": "List of figures", "state": "not_in_csr", "chars": 170, "text": "Figure 1: PRISMA flow (not reported in CSR).Figure 1: Economic model structure (not reported in CSR).No new figures were supplied; original figure locations are retained.", "csr_pages_with_field_terms": null }, { "id": "1792627528", "alias": "Abbreviations", "group": "Abbreviations", "state": "answered", "chars": 300, "cited_pages": [ 25, 26, 27, 28 ], "sentence_checks": [ { "cited": 25, "best": 25, "score": 11, "delta": 0 } ], "numbers": {}, "bracket_cites": 1, "text": "ANCOVA = analysis of covariance; BMI = body mass index; DEXA = dual-energy X-ray absorptiometry; GLP-1 = glucagon-like peptide-1; IWQOL-Lite-CT = Impact of Weight on Quality of Life-Lite for Clinical Trials; MMRM = mixed model for repeated measurements; SAS = safety analysis set. [CSR PDF pp. 25-28]" }, { "id": "198338343", "alias": "Drug under review \u2014 product identification", "group": "Drug under review", "state": "answered", "chars": 261, "cited_pages": [ 39, 40 ], "sentence_checks": [ { "cited": 39, "best": 39, "score": 2, "delta": 0 } ], "numbers": { "1.0": "on_cited_page", "2.4": "on_cited_page", "3.0": "on_cited_page" }, "bracket_cites": 1, "text": "Semaglutide 2.4 mg once weekly, subcutaneous solution for injection. Trial products: 1.0 and 3.0 mg/mL in a 3 mL PDS290 pre-filled pen-injector. [CSR PDF pp. 39-40; Table 9-1] The Wegovy brand and marketed Canadian presentations are not established in this CSR." }, { "id": "538565650", "alias": "Sponsor name", "group": "Sponsor name", "state": "answered", "chars": 64, "cited_pages": [ 2 ], "sentence_checks": [ { "cited": 2, "best": 2, "score": 3, "delta": 0 } ], "numbers": { "2880": "on_cited_page" }, "bracket_cites": 1, "text": "Novo Nordisk, Novo All\u00e9, 2880 Bagsvaerd, Denmark. [CSR PDF p. 2]" }, { "id": "767926277", "alias": "Health Canada indication", "group": "Health Canada indication", "state": "not_in_csr", "chars": 138, "text": "Not reported in the supplied CSR: Canadian indication, approval status/pathway and NOC dates cannot be established from this trial report.", "csr_pages_with_field_terms": 2 }, { "id": "1109251318", "alias": "Health Canada approval status", "group": "Health Canada approval status", "state": "not_in_csr", "chars": 138, "text": "Not reported in the supplied CSR: Canadian indication, approval status/pathway and NOC dates cannot be established from this trial report.", "csr_pages_with_field_terms": 29 }, { "id": "1069967496", "alias": "Health Canada review pathway", "group": "Health Canada review pathway", "state": "not_in_csr", "chars": 138, "text": "Not reported in the supplied CSR: Canadian indication, approval status/pathway and NOC dates cannot be established from this trial report.", "csr_pages_with_field_terms": 1 }, { "id": "1427308873", "alias": "NOC date", "group": "NOC date", "state": "not_in_csr", "chars": 138, "text": "Not reported in the supplied CSR: Canadian indication, approval status/pathway and NOC dates cannot be established from this trial report.", "csr_pages_with_field_terms": null }, { "id": "631054096", "alias": "Mechanism of action", "group": "Mechanism of action", "state": "answered", "chars": 232, "cited_pages": [ 31, 32 ], "sentence_checks": [ { "cited": 31, "best": 32, "score": 3, "delta": 1 } ], "numbers": { "94%": "on_cited_page" }, "bracket_cites": 1, "text": "Semaglutide is a long-acting, selective GLP-1 receptor agonist with 94% homology to human GLP-1. Weight reduction is mediated mainly by reduced energy intake through increased satiety/fullness and reduced hunger. [CSR PDF pp. 31-32]" }, { "id": "1517267069", "alias": "Recommended dosage", "group": "Recommended dosage", "state": "answered", "chars": 414, "cited_pages": [ 39, 40 ], "sentence_checks": [], "numbers": { "0.25": "on_cited_page", "2.4": "on_cited_page", "0.5": "on_cited_page", "1.0": "on_cited_page", "1.7": "on_cited_page" }, "bracket_cites": 1, "text": "Trial regimen: 0.25 mg once weekly for 4 weeks, then 0.5, 1.0 and 1.7 mg once weekly for 4 weeks each, then 2.4 mg once weekly for 52 weeks (68 weeks total). If 2.4 mg was not tolerated, 1.7 mg was permitted to avoid complete discontinuation, with an attempt to re-escalate recommended. [CSR PDF pp. 39-40; Tables 9-1 and 9-2] Product-monograph dosing and subgroup adjustments are not reported in the supplied CSR." }, { "id": "1971185590", "alias": "Submission type", "group": "Submission type", "state": "not_in_csr", "chars": 137, "text": "Not reported in the supplied CSR. The CSR does not provide this Canadian regulatory, reimbursement or prescribing submission information.", "csr_pages_with_field_terms": 0 }, { "id": "1224595166", "alias": "Reimbursement request", "group": "Reimbursement request", "state": "not_in_csr", "chars": 137, "text": "Not reported in the supplied CSR. The CSR does not provide this Canadian regulatory, reimbursement or prescribing submission information.", "csr_pages_with_field_terms": 0 }, { "id": "1846282280", "alias": "Rationale for resubmission or reassessment", "group": "Rationale for resubmission or reassessment", "state": "not_in_csr", "chars": 137, "text": "Not reported in the supplied CSR. The CSR does not provide this Canadian regulatory, reimbursement or prescribing submission information.", "csr_pages_with_field_terms": 0 }, { "id": "80408254", "alias": "Indication and reimbursement request", "group": "Indication and reimbursement request", "state": "not_in_csr", "chars": 137, "text": "Not reported in the supplied CSR. The CSR does not provide this Canadian regulatory, reimbursement or prescribing submission information.", "csr_pages_with_field_terms": 0 }, { "id": "230650760", "alias": "Drug under review \u2014 dosing and administration", "group": "Drug under review", "state": "answered", "chars": 414, "cited_pages": [ 39, 40 ], "sentence_checks": [], "numbers": { "0.25": "on_cited_page", "2.4": "on_cited_page", "0.5": "on_cited_page", "1.0": "on_cited_page", "1.7": "on_cited_page" }, "bracket_cites": 1, "text": "Trial regimen: 0.25 mg once weekly for 4 weeks, then 0.5, 1.0 and 1.7 mg once weekly for 4 weeks each, then 2.4 mg once weekly for 52 weeks (68 weeks total). If 2.4 mg was not tolerated, 1.7 mg was permitted to avoid complete discontinuation, with an attempt to re-escalate recommended. [CSR PDF pp. 39-40; Tables 9-1 and 9-2] Product-monograph dosing and subgroup adjustments are not reported in the supplied CSR." }, { "id": "600835751", "alias": "Drug under review \u2014 mechanism of action", "group": "Drug under review", "state": "answered", "chars": 232, "cited_pages": [ 31, 32 ], "sentence_checks": [ { "cited": 31, "best": 32, "score": 3, "delta": 1 } ], "numbers": { "94%": "on_cited_page" }, "bracket_cites": 1, "text": "Semaglutide is a long-acting, selective GLP-1 receptor agonist with 94% homology to human GLP-1. Weight reduction is mediated mainly by reduced energy intake through increased satiety/fullness and reduced hunger. [CSR PDF pp. 31-32]" }, { "id": "1321906422", "alias": "Drug under review \u2014 prescribing restrictions", "group": "Drug under review", "state": "not_in_csr", "chars": 137, "text": "Not reported in the supplied CSR. The CSR does not provide this Canadian regulatory, reimbursement or prescribing submission information.", "csr_pages_with_field_terms": 0 }, { "id": "1010375957", "alias": "Disease background \u2014 overview of condition", "group": "Disease background", "state": "answered", "chars": 714, "cited_pages": [ 31 ], "sentence_checks": [ { "cited": 31, "best": 31, "score": 13, "delta": 0 } ], "numbers": { "-10%": "on_cited_page", "5%": "on_cited_page" }, "bracket_cites": 1, "text": "Obesity is described as a disease with substantial medical, societal and economic impact, reduced health-related quality of life, and increased morbidity and mortality. Associated complications include type 2 diabetes, hypertension, dyslipidaemia, sleep apnoea, cardiovascular disease, osteoarthritis, urinary incontinence, non-alcoholic steatohepatitis and some cancers. Risk increases with BMI; 5%-10% weight loss can improve comorbidities, physical symptoms and quality of life. Lifestyle-induced weight loss is opposed by increased appetite and reduced energy expenditure, contributing to regain." }, { "id": "1862541793", "alias": "Disease background \u2014 estimated disease prevalence narrative", "group": "Disease background", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 23 }, { "id": "1961078454", "alias": "Estimated prevalence \u2014 Pan-Canadian excluding Quebec \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "547920550", "alias": "Estimated prevalence \u2014 Pan-Canadian excluding Quebec \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "2020580078", "alias": "Estimated prevalence \u2014 Pan-Canadian excluding Quebec \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "862513230", "alias": "Estimated prevalence \u2014 Alberta \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "399868640", "alias": "Estimated prevalence \u2014 Alberta \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "1049388599", "alias": "Estimated prevalence \u2014 Alberta \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "743271500", "alias": "Estimated prevalence \u2014 British Columbia \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "1387299603", "alias": "Estimated prevalence \u2014 British Columbia \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "802424613", "alias": "Estimated prevalence \u2014 British Columbia \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "707348494", "alias": "Estimated prevalence \u2014 Manitoba \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "1054949687", "alias": "Estimated prevalence \u2014 Manitoba \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "471519582", "alias": "Estimated prevalence \u2014 Manitoba \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "843183767", "alias": "Estimated prevalence \u2014 New Brunswick \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "1929617225", "alias": "Estimated prevalence \u2014 New Brunswick \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "1285642913", "alias": "Estimated prevalence \u2014 New Brunswick \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "128992369", "alias": "Estimated prevalence \u2014 Newfoundland and Labrador \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "379697995", "alias": "Estimated prevalence \u2014 Newfoundland and Labrador \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "1437339656", "alias": "Estimated prevalence \u2014 Newfoundland and Labrador \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "889081692", "alias": "Estimated prevalence \u2014 Northwest Territories \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "1025526835", "alias": "Estimated prevalence \u2014 Northwest Territories \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "1233515049", "alias": "Estimated prevalence \u2014 Northwest Territories \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "1926722373", "alias": "Estimated prevalence \u2014 Nova Scotia \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "865436102", "alias": "Estimated prevalence \u2014 Nova Scotia \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "1028952913", "alias": "Estimated prevalence \u2014 Nova Scotia \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "1164403495", "alias": "Estimated prevalence \u2014 Nunavut \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "1818044526", "alias": "Estimated prevalence \u2014 Nunavut \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "1638920587", "alias": "Estimated prevalence \u2014 Nunavut \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "523553245", "alias": "Estimated prevalence \u2014 Ontario \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "1576426057", "alias": "Estimated prevalence \u2014 Ontario \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "857628237", "alias": "Estimated prevalence \u2014 Ontario \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "1425175969", "alias": "Estimated prevalence \u2014 Prince Edward Island \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "503914152", "alias": "Estimated prevalence \u2014 Prince Edward Island \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "244229309", "alias": "Estimated prevalence \u2014 Prince Edward Island \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "50866461", "alias": "Estimated prevalence \u2014 Saskatchewan \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "1870012319", "alias": "Estimated prevalence \u2014 Saskatchewan \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "1477188374", "alias": "Estimated prevalence \u2014 Saskatchewan \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "1187982909", "alias": "Estimated prevalence \u2014 Yukon \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 5 }, { "id": "1237249317", "alias": "Estimated prevalence \u2014 Yukon \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "1079986308", "alias": "Estimated prevalence \u2014 Yukon \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "106495390", "alias": "Estimated prevalence \u2014 Non-Insured Health Benefits \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 13 }, { "id": "1128413559", "alias": "Estimated prevalence \u2014 Non-Insured Health Benefits \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 7 }, { "id": "1512039669", "alias": "Estimated prevalence \u2014 Non-Insured Health Benefits \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 90, "text": "Not reported in the supplied CSR: Canadian regional prevalence estimates are not provided.", "csr_pages_with_field_terms": 7 }, { "id": "1333223319", "alias": "Diagnosis \u2014 diagnostic testing requirements", "group": "Diagnosis", "state": "answered", "chars": 565, "cited_pages": [ 37, 38 ], "sentence_checks": [ { "cited": 37, "best": 37, "score": 6, "delta": 0 } ], "numbers": {}, "bracket_cites": 2, "text": "Adults \u226518 years with BMI \u226530 kg/m\u00b2, or \u226527 kg/m\u00b2 with \u22651 treated or untreated weight-related comorbidity (hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease), and \u22651 self-reported unsuccessful dietary weight-loss effort. [CSR PDF p. 37] Trial screening assessed eligibility, HbA1c, mental health using PHQ-9/C-SSRS, and weight/height for BMI; baseline assessments preceded the first dose. [CSR PDF pp. 37-38,43-46] Canadian diagnostic availability, professional restrictions and product-monograph testing requirements are not reported." }, { "id": "804539857", "alias": "Diagnosis \u2014 availability of diagnostic testing", "group": "Diagnosis", "state": "not_in_csr", "chars": 96, "text": "Not reported in the supplied CSR. Canadian test access and access initiatives are not described.", "csr_pages_with_field_terms": 1 }, { "id": "193925407", "alias": "Health Care Resources - Pre-treatment phase", "group": "Health Care Resources", "state": "not_in_csr", "chars": 336, "text": "Trial preparation included screening/eligibility assessment, informed consent, food diary instruction, a barriers-and-motivation interview, fasting baseline assessments, diet/activity counselling and pen-handling training. [CSR PDF pp. 43-44] Required Canadian pre-treatment drugs, procedures and rec", "csr_pages_with_field_terms": 3 }, { "id": "1753192794", "alias": "Health care resources \u2014 treatment phase", "group": "Health care resources", "state": "answered", "chars": 859, "cited_pages": [ 39, 40, 41, 42 ], "sentence_checks": [ { "cited": 39, "best": 61, "score": 2, "delta": 22 } ], "numbers": { "0.25": "on_cited_page", "2.4": "on_cited_page", "500": "on_cited_page", "0.5": "on_cited_page", "150": "on_cited_page", "1.0": "on_cited_page", "1.7": "on_cited_page" }, "bracket_cites": 3, "text": "Trial regimen: 0.25 mg once weekly for 4 weeks, then 0.5, 1.0 and 1.7 mg once weekly for 4 weeks each, then 2.4 mg once weekly for 52 weeks (68 weeks total). If 2.4 mg was not tolerated, 1.7 mg was permitted to avoid complete discontinuation, with an attempt to re-escalate recommended. [CSR PDF pp. 39-40; Tables 9-1 and 9-2] Matched placebo injection once weekly using the same pen and escalating volumes for 68 weeks; both groups received diet counselling targeting a 500 kcal/day deficit and \u2265150 minutes/week physical activity, with counselling every 4 weeks. [CSR PDF pp. 39-42] Subjects receiv" }, { "id": "1278843648", "alias": "Health Care Resources - Post-treatment phase", "group": "Health Care Resources", "state": "not_in_csr", "chars": 264, "text": "A safety follow-up visit was scheduled 7 weeks after treatment ended, including fasting attendance, to account for semaglutide\u2019s long half-life. [CSR PDF pp. 35,44] Post-treatment Canadian drugs, hospitalization and recovery resource requirements are not reported.", "csr_pages_with_field_terms": 4 }, { "id": "1769136716", "alias": "Place in therapy \u2014 current treatment paradigm", "group": "Place in therapy", "state": "not_in_csr", "chars": 394, "text": "CSR background describes reduced-calorie diet and increased activity as first-line treatment, bariatric surgery as an option for some people with severe obesity, and pharmacotherapy as a potential alternative to achieve and sustain weight loss and improve comorbidities. [CSR PDF pp. 31,36] Current C", "csr_pages_with_field_terms": 7 }, { "id": "313885677", "alias": "Place in therapy \u2014 unmet therapeutic needs", "group": "Place in therapy", "state": "answered", "chars": 266, "cited_pages": [ 31 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "The CSR identifies difficulty achieving and maintaining weight loss with lifestyle intervention, procedural/follow-up burdens of surgery and the need for safer, effective, convenient medicines supporting weight maintenance and comorbidity management. [CSR PDF p. 31]" }, { "id": "703979793", "alias": "Place in therapy \u2014 proposed place in therapy", "group": "Place in therapy", "state": "not_in_csr", "chars": 264, "text": "The trial rationale positions semaglutide 2.4 mg as an adjunct to reduced-calorie diet and increased physical activity in adults with overweight/obesity after an unsuccessful dietary effort. [CSR PDF pp. 32,36-37] A Canadian reimbursement sequence is not reported.", "csr_pages_with_field_terms": 5 }, { "id": "678809355", "alias": "Place in therapy \u2014 impact on currently reimbursed treatments", "group": "Place in therapy", "state": "not_in_csr", "chars": 120, "text": "Not reported in the supplied CSR. No Canadian reimbursement-impact analysis or treatment-sequencing diagram is provided.", "csr_pages_with_field_terms": 5 }, { "id": "1892960731", "alias": "Provisional algorithm diagram - description", "group": "Provisional algorithm diagram", "state": "not_in_csr", "chars": 120, "text": "Not reported in the supplied CSR. No Canadian reimbursement-impact analysis or treatment-sequencing diagram is provided.", "csr_pages_with_field_terms": 0 }, { "id": "518136981", "alias": "Place in therapy \u2014 provisional algorithm figure", "group": "Place in therapy", "state": "not_in_csr", "chars": 120, "text": "Not reported in the supplied CSR. No Canadian reimbursement-impact analysis or treatment-sequencing diagram is provided.", "csr_pages_with_field_terms": 1 }, { "id": "1759026699", "alias": "Comparators description", "group": "Comparators description", "state": "not_in_csr", "chars": 311, "text": "Matched placebo injection once weekly using the same pen and escalating volumes for 68 weeks; both groups received diet counselling targeting a 500 kcal/day deficit and \u2265150 minutes/week physical activity, with counselling every 4 weeks. [CSR PDF pp. 39-42] Canadian economic-model comparators are no", "csr_pages_with_field_terms": 0 }, { "id": "284852098", "alias": "Comparators \u2014 drug under review name", "group": "Comparators", "state": "answered", "chars": 27, "cited_pages": [ 40 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Semaglutide [CSR PDF p. 40]" }, { "id": "1583495440", "alias": "Comparators \u2014 drug under review indication", "group": "Comparators", "state": "not_in_csr", "chars": 312, "text": "Adults \u226518 years with BMI \u226530 kg/m\u00b2, or \u226527 kg/m\u00b2 with \u22651 treated or untreated weight-related comorbidity (hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease), and \u22651 self-reported unsuccessful dietary weight-loss effort. [CSR PDF p. 37] Canadian approved indication is n", "csr_pages_with_field_terms": 0 }, { "id": "1189929439", "alias": "Comparators \u2014 drug under review regimen", "group": "Comparators", "state": "answered", "chars": 326, "cited_pages": [ 39, 40 ], "sentence_checks": [], "numbers": { "0.25": "on_cited_page", "2.4": "on_cited_page", "0.5": "on_cited_page", "1.0": "on_cited_page", "1.7": "on_cited_page" }, "bracket_cites": 1, "text": "Trial regimen: 0.25 mg once weekly for 4 weeks, then 0.5, 1.0 and 1.7 mg once weekly for 4 weeks each, then 2.4 mg once weekly for 52 weeks (68 weeks total). If 2.4 mg was not tolerated, 1.7 mg was permitted to avoid complete discontinuation, with an attempt to re-escalate recommended. [CSR PDF pp. 39-40; Tables 9-1 and 9-2]" }, { "id": "1472527722", "alias": "Comparators \u2014 comparator 1 name", "group": "Comparators", "state": "answered", "chars": 55, "cited_pages": [ 39, 40, 41 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Placebo plus lifestyle intervention [CSR PDF pp. 39-41]" }, { "id": "351979935", "alias": "Comparators \u2014 comparator 1 indication", "group": "Comparators", "state": "not_in_csr", "chars": 106, "text": "Not applicable: trial placebo comparator. Used as control with lifestyle intervention. [CSR PDF pp. 37,41]", "csr_pages_with_field_terms": 0 }, { "id": "1248902499", "alias": "Comparators \u2014 comparator 1 regimen", "group": "Comparators", "state": "answered", "chars": 257, "cited_pages": [ 39, 40, 41, 42 ], "sentence_checks": [ { "cited": 39, "best": 61, "score": 2, "delta": 22 } ], "numbers": { "150": "on_cited_page", "500": "on_cited_page" }, "bracket_cites": 1, "text": "Matched placebo injection once weekly using the same pen and escalating volumes for 68 weeks; both groups received diet counselling targeting a 500 kcal/day deficit and \u2265150 minutes/week physical activity, with counselling every 4 weeks. [CSR PDF pp. 39-42]" }, { "id": "2138645005", "alias": "Comparators \u2014 comparator 1 indirect comparison rationale", "group": "Comparators", "state": "not_in_csr", "chars": 100, "text": "Not reported in the supplied CSR. Systematic-review/economic-evaluation inclusion is not documented.", "csr_pages_with_field_terms": 0 }, { "id": "1584295274", "alias": "Comparators \u2014 comparator 1 pharmacoeconomic evaluation rationale", "group": "Comparators", "state": "not_in_csr", "chars": 100, "text": "Not reported in the supplied CSR. Systematic-review/economic-evaluation inclusion is not documented.", "csr_pages_with_field_terms": 1 }, { "id": "56679918", "alias": "Comparators \u2014 comparator 2 name", "group": "Comparators", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1139272176", "alias": "Comparators \u2014 comparator 2 indication", "group": "Comparators", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1671645521", "alias": "Comparators \u2014 comparator 2 regimen", "group": "Comparators", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1471605575", "alias": "Comparators \u2014 comparator 2 indirect comparison rationale", "group": "Comparators", "state": "not_in_csr", "chars": 100, "text": "Not reported in the supplied CSR. Systematic-review/economic-evaluation inclusion is not documented.", "csr_pages_with_field_terms": 0 }, { "id": "1117325907", "alias": "Comparators \u2014 comparator 2 pharmacoeconomic evaluation rationale", "group": "Comparators", "state": "not_in_csr", "chars": 100, "text": "Not reported in the supplied CSR. Systematic-review/economic-evaluation inclusion is not documented.", "csr_pages_with_field_terms": 1 }, { "id": "451938502", "alias": "Comparators \u2014 data sources", "group": "Comparators", "state": "answered", "chars": 141, "cited_pages": [ 39, 40, 41 ], "sentence_checks": [], "numbers": { "9.4": "on_cited_page" }, "bracket_cites": 1, "text": "Trial products and regimens: Tables 9-1 and 9-2; counselling: section 9.4.1.2. No Canadian product monograph is supplied. [CSR PDF pp. 39-41]" }, { "id": "691662644", "alias": "Proposed reimbursement conditions", "group": "Proposed reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 0 }, { "id": "115541822", "alias": "Reimbursement conditions \u2014 initiation condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 1 }, { "id": "1440032977", "alias": "Reimbursement conditions \u2014 initiation rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 0 }, { "id": "1774983937", "alias": "Reimbursement conditions \u2014 initiation alignment condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 1 }, { "id": "1288836516", "alias": "Reimbursement conditions \u2014 initiation alignment rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 0 }, { "id": "198562177", "alias": "Reimbursement conditions \u2014 renewal condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 1 }, { "id": "1469981911", "alias": "Reimbursement conditions \u2014 renewal rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 0 }, { "id": "593079894", "alias": "Reimbursement conditions \u2014 renewal alignment condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 1 }, { "id": "181289987", "alias": "Reimbursement conditions \u2014 renewal alignment rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 0 }, { "id": "806644934", "alias": "Reimbursement conditions \u2014 discontinuation condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 3 }, { "id": "1088305840", "alias": "Reimbursement conditions \u2014 discontinuation rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 2 }, { "id": "1138168675", "alias": "Reimbursement conditions \u2014 prescribing condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 1 }, { "id": "1817405152", "alias": "Reimbursement conditions \u2014 prescribing rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 113, "text": "Not reported in the supplied CSR: proposed reimbursement conditions and their sponsor rationale are not provided.", "csr_pages_with_field_terms": 0 }, { "id": "1985672964", "alias": "Reimbursement conditions - Abbreviations", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 90, "text": "No reimbursement-condition abbreviations required; conditions are not reported in the CSR.", "csr_pages_with_field_terms": 0 }, { "id": "344607807", "alias": "Systematic review \u2014 objective", "group": "Systematic review", "state": "answered", "chars": 242, "cited_pages": [ 33 ], "sentence_checks": [], "numbers": { "2.4": "on_cited_page" }, "bracket_cites": 1, "text": "Trial objective: compare semaglutide 2.4 mg weekly versus placebo, adjunctive to diet/activity, for weight loss, efficacy and safety in adults with overweight or obesity. [CSR PDF p. 33] A systematic-review objective/protocol is not supplied." }, { "id": "1711002088", "alias": "Review protocol PICO - Population", "group": "Review protocol PICO", "state": "not_in_csr", "chars": 353, "text": "Adults \u226518 years with BMI \u226530 kg/m\u00b2, or \u226527 kg/m\u00b2 with \u22651 treated or untreated weight-related comorbidity (hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease), and \u22651 self-reported unsuccessful dietary weight-loss effort. [CSR PDF p. 37] Canadian label-defined review pop", "csr_pages_with_field_terms": 5 }, { "id": "1669481612", "alias": "Review protocol PICO - Intervention", "group": "Review protocol PICO", "state": "answered", "chars": 588, "cited_pages": [ 39, 40 ], "sentence_checks": [ { "cited": 39, "best": 39, "score": 2, "delta": 0 } ], "numbers": { "0.25": "on_cited_page", "2.4": "on_cited_page", "0.5": "on_cited_page", "1.0": "on_cited_page", "3.0": "on_cited_page", "1.7": "on_cited_page" }, "bracket_cites": 2, "text": "Semaglutide 2.4 mg once weekly, subcutaneous solution for injection. Trial products: 1.0 and 3.0 mg/mL in a 3 mL PDS290 pre-filled pen-injector. [CSR PDF pp. 39-40; Table 9-1] The Wegovy brand and marketed Canadian presentations are not established in this CSR. Trial regimen: 0.25 mg once weekly for 4 weeks, then 0.5, 1.0 and 1.7 mg once weekly for 4 weeks each, then 2.4 mg once weekly for 52 weeks (68 weeks total). If 2.4 mg was not tolerated, 1.7 mg was permitted to avoid complete discontinuation, with an attempt to re-escalate recommended. [CSR PDF pp. 39-40; Tables 9-1 and 9-2]" }, { "id": "1768930", "alias": "Review protocol PICO - Comparator(s)", "group": "Review protocol PICO", "state": "not_in_csr", "chars": 334, "text": "Matched placebo injection once weekly using the same pen and escalating volumes for 68 weeks; both groups received diet counselling targeting a 500 kcal/day deficit and \u2265150 minutes/week physical activity, with counselling every 4 weeks. [CSR PDF pp. 39-42] A Canadian systematic-review/economic-mode", "csr_pages_with_field_terms": 0 }, { "id": "350684775", "alias": "Review protocol PICO - Outcomes", "group": "Review protocol PICO", "state": "answered", "chars": 1022, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [ { "cited": 59, "best": 125, "score": 10, "delta": 66 }, { "cited": 61, "best": 15, "score": 2, "delta": 46 } ], "numbers": { "68,": "on_cited_page", "5%": "on_cited_page", "20%": "on_cited_page", "15%": "on_cited_page", "10%": "on_cited_page" }, "bracket_cites": 3, "text": "Change in body weight (%) from week 0 to week 68, and achieving \u22655% baseline body-weight reduction at week 68. [CSR PDF p. 59; Table 9-8] Confirmatory: \u226510% and \u226515% weight loss at week 68; baseline-to-week-68 change in waist circumference, systolic blood pressure, SF-36 physical functioning and IWQOL-Lite-CT physical function. Supportive: \u226520% loss; weight (kg), BMI, diastolic pressure, lipids, CRP, PAI-1, other SF-36/IWQOL scores and physical-function responders, HbA1c, fasting glucose/insulin, leptin and soluble leptin receptor, and DEXA body composition/weight. Safety: TEAEs/SAEs through w" }, { "id": "909017236", "alias": "Review protocol PICO - Study design", "group": "Review protocol PICO", "state": "answered", "chars": 193, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "4373": "on_cited_page" }, "bracket_cites": 1, "text": "One phase 3a, randomised, double-blind, parallel-group, placebo-controlled trial: STEP 1 (NN9536-4373). [CSR PDF pp. 2,35] A systematic-review study-design eligibility protocol is not supplied." }, { "id": "390680609", "alias": "Inclusion criteria table \u2014 number", "group": "Inclusion criteria table", "state": "answered", "chars": 1, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "2" }, { "id": "1880349076", "alias": "Inclusion criteria \u2014 population", "group": "Inclusion criteria", "state": "answered", "chars": 266, "cited_pages": [ 37 ], "sentence_checks": [ { "cited": 37, "best": 37, "score": 6, "delta": 0 } ], "numbers": {}, "bracket_cites": 1, "text": "Adults \u226518 years with BMI \u226530 kg/m\u00b2, or \u226527 kg/m\u00b2 with \u22651 treated or untreated weight-related comorbidity (hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease), and \u22651 self-reported unsuccessful dietary weight-loss effort. [CSR PDF p. 37]" }, { "id": "2015476795", "alias": "Inclusion criteria \u2014 relevant subgroups", "group": "Inclusion criteria", "state": "answered", "chars": 258, "cited_pages": [ 38 ], "sentence_checks": [], "numbers": { "140": "elsewhere" }, "bracket_cites": 1, "text": "DEXA body-composition subpopulation: acceptable baseline scan and BMI \u226440 kg/m\u00b2; 140 participants (95 semaglutide; 45 placebo). [CSR PDF pp. 38,72] No systematic-review subgroup list or efficacy treatment-by-subgroup analysis is reported in the supplied CSR." }, { "id": "732486507", "alias": "Inclusion criteria \u2014 intervention", "group": "Inclusion criteria", "state": "answered", "chars": 326, "cited_pages": [ 39, 40 ], "sentence_checks": [], "numbers": { "0.25": "on_cited_page", "2.4": "on_cited_page", "0.5": "on_cited_page", "1.0": "on_cited_page", "1.7": "on_cited_page" }, "bracket_cites": 1, "text": "Trial regimen: 0.25 mg once weekly for 4 weeks, then 0.5, 1.0 and 1.7 mg once weekly for 4 weeks each, then 2.4 mg once weekly for 52 weeks (68 weeks total). If 2.4 mg was not tolerated, 1.7 mg was permitted to avoid complete discontinuation, with an attempt to re-escalate recommended. [CSR PDF pp. 39-40; Tables 9-1 and 9-2]" }, { "id": "724565510", "alias": "Inclusion criteria \u2014 comparators", "group": "Inclusion criteria", "state": "answered", "chars": 257, "cited_pages": [ 39, 40, 41, 42 ], "sentence_checks": [ { "cited": 39, "best": 61, "score": 2, "delta": 22 } ], "numbers": { "150": "on_cited_page", "500": "on_cited_page" }, "bracket_cites": 1, "text": "Matched placebo injection once weekly using the same pen and escalating volumes for 68 weeks; both groups received diet counselling targeting a 500 kcal/day deficit and \u2265150 minutes/week physical activity, with counselling every 4 weeks. [CSR PDF pp. 39-42]" }, { "id": "701037126", "alias": "Inclusion criteria \u2014 efficacy outcomes", "group": "Inclusion criteria", "state": "answered", "chars": 1022, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [ { "cited": 59, "best": 125, "score": 10, "delta": 66 }, { "cited": 61, "best": 15, "score": 2, "delta": 46 } ], "numbers": { "68,": "on_cited_page", "5%": "on_cited_page", "20%": "on_cited_page", "15%": "on_cited_page", "10%": "on_cited_page" }, "bracket_cites": 3, "text": "Change in body weight (%) from week 0 to week 68, and achieving \u22655% baseline body-weight reduction at week 68. [CSR PDF p. 59; Table 9-8] Confirmatory: \u226510% and \u226515% weight loss at week 68; baseline-to-week-68 change in waist circumference, systolic blood pressure, SF-36 physical functioning and IWQOL-Lite-CT physical function. Supportive: \u226520% loss; weight (kg), BMI, diastolic pressure, lipids, CRP, PAI-1, other SF-36/IWQOL scores and physical-function responders, HbA1c, fasting glucose/insulin, leptin and soluble leptin receptor, and DEXA body composition/weight. Safety: TEAEs/SAEs through w" }, { "id": "473002630", "alias": "Inclusion criteria \u2014 harms outcomes", "group": "Inclusion criteria", "state": "answered", "chars": 279, "cited_pages": [ 61 ], "sentence_checks": [ { "cited": 61, "best": 22, "score": 2, "delta": 39 } ], "numbers": {}, "bracket_cites": 1, "text": "TEAEs, SAEs, permanent discontinuation/temporary interruption due to AEs, deaths, and safety focus areas including gastrointestinal, gallbladder, pancreatitis, cardiovascular, neoplastic, hepatic, renal, hypoglycaemic, immunogenic and psychiatric events. [CSR PDF pp. 61,128-129]" }, { "id": "890642733", "alias": "Inclusion criteria \u2014 study designs", "group": "Inclusion criteria", "state": "answered", "chars": 193, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "4373": "on_cited_page" }, "bracket_cites": 1, "text": "One phase 3a, randomised, double-blind, parallel-group, placebo-controlled trial: STEP 1 (NN9536-4373). [CSR PDF pp. 2,35] A systematic-review study-design eligibility protocol is not supplied." }, { "id": "486984095", "alias": "PICO table - Abbreviations", "group": "PICO table", "state": "answered", "chars": 214, "cited_pages": [ 48, 49, 50, 51, 52, 53, 54 ], "sentence_checks": [], "numbers": { "9.5": "on_cited_page" }, "bracket_cites": 1, "text": "AE = adverse event; AESI = adverse event of special interest; SAE = serious adverse event; WDAE = withdrawal due to adverse event. Safety categories are defined in sections 9.5.4 and 12. [CSR PDF pp. 48-54,128-129]" }, { "id": "1663243863", "alias": "Literature search methodology", "group": "Literature search methodology", "state": "not_in_csr", "chars": 106, "text": "Not reported in the supplied CSR: no systematic literature search or review-selection process is provided.", "csr_pages_with_field_terms": 1 }, { "id": "1154094977", "alias": "Literature search methods \u2014 indication or population", "group": "Literature search methods", "state": "not_in_csr", "chars": 106, "text": "Not reported in the supplied CSR: no systematic literature search or review-selection process is provided.", "csr_pages_with_field_terms": 2 }, { "id": "364360071", "alias": "Literature search methods \u2014 initial search date", "group": "Literature search methods", "state": "not_in_csr", "chars": 106, "text": "Not reported in the supplied CSR: no systematic literature search or review-selection process is provided.", "csr_pages_with_field_terms": 48 }, { "id": "1775098485", "alias": "PRISMA flow diagram \u2014 figure number", "group": "PRISMA flow diagram", "state": "answered", "chars": 1, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "1" }, { "id": "1281811044", "alias": "Study selection \u2014 PRISMA flow diagram", "group": "Study selection", "state": "not_in_csr", "chars": 106, "text": "Not reported in the supplied CSR: no systematic literature search or review-selection process is provided.", "csr_pages_with_field_terms": 0 }, { "id": "1712953180", "alias": "Included studies table \u2014 number", "group": "Included studies table", "state": "answered", "chars": 1, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "3" }, { "id": "917274444", "alias": "Included studies \u2014 Study 1 name", "group": "Included studies", "state": "answered", "chars": 48, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "4373": "on_cited_page" }, "bracket_cites": 1, "text": "STEP 1 (NN9536-4373; NCT03548935) [CSR PDF p. 2]" }, { "id": "197412906", "alias": "Included studies \u2014 Study 2 name", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1930116000", "alias": "Included studies \u2014 Study 1 design", "group": "Included studies", "state": "answered", "chars": 126, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Phase 3a, multicentre, multinational, randomised (2:1), double-blind, placebo-controlled, two-arm trial. [CSR PDF pp. 2,35,42]" }, { "id": "1565938690", "alias": "Included studies \u2014 Study 2 design", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1676867584", "alias": "Included studies \u2014 Study 1 locations", "group": "Included studies", "state": "answered", "chars": 193, "cited_pages": [ 2 ], "sentence_checks": [ { "cited": 2, "best": 28, "score": 11, "delta": 26 } ], "numbers": { "129": "on_cited_page" }, "bracket_cites": 1, "text": "129 sites in 16 countries: Argentina, Belgium, Bulgaria, Canada (7 sites), Denmark, Finland, France, Germany, India, Japan, Mexico, Poland, Russian Federation, Taiwan, UK and US. [CSR PDF p. 2]" }, { "id": "908712584", "alias": "Included studies \u2014 Study 2 locations", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1994652249", "alias": "Included studies \u2014 Study 1 enrolment start date", "group": "Included studies", "state": "answered", "chars": 37, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "2018": "on_cited_page" }, "bracket_cites": 1, "text": "Initiated 4 June 2018. [CSR PDF p. 2]" }, { "id": "933644844", "alias": "Included studies \u2014 Study 1 enrolment end date", "group": "Included studies", "state": "answered", "chars": 73, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "2020": "on_cited_page" }, "bracket_cites": 1, "text": "Completed 19 April 2020; primary completion 30 March 2020. [CSR PDF p. 2]" }, { "id": "756660477", "alias": "Included studies \u2014 Study 2 enrolment start date", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1664939013", "alias": "Included studies \u2014 Study 2 enrolment end date", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1838953778", "alias": "Included studies \u2014 Study 1 randomized enrolment", "group": "Included studies", "state": "answered", "chars": 66, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "1306": "on_cited_page", "655": "on_cited_page", "1961": "on_cited_page" }, "bracket_cites": 1, "text": "N=1961: semaglutide 1306; placebo 655. [CSR PDF p. 65; Table 10-1]" }, { "id": "757931386", "alias": "Included studies \u2014 Study 2 randomized enrolment", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1875361923", "alias": "Included studies \u2014 Study 1 inclusion criteria", "group": "Included studies", "state": "answered", "chars": 266, "cited_pages": [ 37 ], "sentence_checks": [ { "cited": 37, "best": 37, "score": 6, "delta": 0 } ], "numbers": {}, "bracket_cites": 1, "text": "Adults \u226518 years with BMI \u226530 kg/m\u00b2, or \u226527 kg/m\u00b2 with \u22651 treated or untreated weight-related comorbidity (hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease), and \u22651 self-reported unsuccessful dietary weight-loss effort. [CSR PDF p. 37]" }, { "id": "1464404542", "alias": "Included studies \u2014 Study 2 inclusion criteria", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1338957035", "alias": "Included studies \u2014 Study 1 exclusion criteria", "group": "Included studies", "state": "answered", "chars": 557, "cited_pages": [ 37, 38 ], "sentence_checks": [ { "cited": 37, "best": 209, "score": 3, "delta": 172 } ], "numbers": { "6.5%": "on_cited_page", "180": "elsewhere" }, "bracket_cites": 1, "text": "Key exclusions: HbA1c \u22656.5%; weight change >5 kg within 90 days; history of type 1/type 2 diabetes; uncontrolled thyroid disease; severe psychiatric disorders/major depression and suicidality criteria; pregnancy/breast-feeding or inadequate contraception. Prior glucose-lowering drugs (90 days), GLP-1 RA (180 days), obesity medication (90 days), and prior/planned bariatric surgery/device were restricted. Randomisation additionally required food diary adherence, PHQ-9 <15 and no specified suicidal behaviour/ideation. [CSR PDF pp. 37-38,43,209-210]" }, { "id": "1008430582", "alias": "Included studies \u2014 Study 2 exclusion criteria", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "2066905324", "alias": "Included studies \u2014 Study 1 intervention regimen", "group": "Included studies", "state": "answered", "chars": 326, "cited_pages": [ 39, 40 ], "sentence_checks": [], "numbers": { "0.25": "on_cited_page", "2.4": "on_cited_page", "0.5": "on_cited_page", "1.0": "on_cited_page", "1.7": "on_cited_page" }, "bracket_cites": 1, "text": "Trial regimen: 0.25 mg once weekly for 4 weeks, then 0.5, 1.0 and 1.7 mg once weekly for 4 weeks each, then 2.4 mg once weekly for 52 weeks (68 weeks total). If 2.4 mg was not tolerated, 1.7 mg was permitted to avoid complete discontinuation, with an attempt to re-escalate recommended. [CSR PDF pp. 39-40; Tables 9-1 and 9-2]" }, { "id": "1616047389", "alias": "Included studies \u2014 Study 2 intervention regimen", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1885629606", "alias": "Included studies \u2014 Study 1 comparators", "group": "Included studies", "state": "answered", "chars": 257, "cited_pages": [ 39, 40, 41, 42 ], "sentence_checks": [ { "cited": 39, "best": 61, "score": 2, "delta": 22 } ], "numbers": { "150": "on_cited_page", "500": "on_cited_page" }, "bracket_cites": 1, "text": "Matched placebo injection once weekly using the same pen and escalating volumes for 68 weeks; both groups received diet counselling targeting a 500 kcal/day deficit and \u2265150 minutes/week physical activity, with counselling every 4 weeks. [CSR PDF pp. 39-42]" }, { "id": "1684065809", "alias": "Included studies \u2014 Study 2 comparators", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "290423608", "alias": "Included studies \u2014 Study 1 screening duration", "group": "Included studies", "state": "answered", "chars": 74, "cited_pages": [ 35 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Screening at week -1, randomisation at week 0. [CSR PDF p. 35; Figure 9-1]" }, { "id": "442195305", "alias": "Included studies \u2014 Study 2 screening duration", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1567489723", "alias": "Included studies \u2014 Study 1 run-in duration", "group": "Included studies", "state": "answered", "chars": 121, "cited_pages": [ 35 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No separate treatment run-in; a screening interval and food diary requirement preceded randomisation. [CSR PDF pp. 35,38]" }, { "id": "547609463", "alias": "Included studies \u2014 Study 2 run-in duration", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1581181457", "alias": "Included studies \u2014 Study 1 treatment duration", "group": "Included studies", "state": "answered", "chars": 74, "cited_pages": [ 35 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "68 weeks: 16-week escalation plus 52-week maintenance. [CSR PDF pp. 35,40]" }, { "id": "1637983798", "alias": "Included studies \u2014 Study 2 treatment duration", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1316176492", "alias": "Included studies \u2014 Study 1 follow-up duration", "group": "Included studies", "state": "answered", "chars": 166, "cited_pages": [ 35, 36 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "7-week off-treatment safety follow-up (week 75); selected participants could enter a planned 52-week off-treatment extension, reported separately. [CSR PDF pp. 35-36]" }, { "id": "155452583", "alias": "Included studies \u2014 Study 2 follow-up duration", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1244553497", "alias": "Included studies \u2014 Study 1 primary endpoint", "group": "Included studies", "state": "answered", "chars": 137, "cited_pages": [ 59 ], "sentence_checks": [], "numbers": { "68,": "on_cited_page", "5%": "on_cited_page" }, "bracket_cites": 1, "text": "Change in body weight (%) from week 0 to week 68, and achieving \u22655% baseline body-weight reduction at week 68. [CSR PDF p. 59; Table 9-8]" }, { "id": "625389978", "alias": "Included studies \u2014 Study 2 primary endpoint", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "826306291", "alias": "Included studies \u2014 Study 1 secondary endpoints", "group": "Included studies", "state": "answered", "chars": 557, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [ { "cited": 59, "best": 125, "score": 10, "delta": 66 } ], "numbers": { "20%": "on_cited_page", "15%": "on_cited_page", "10%": "on_cited_page" }, "bracket_cites": 1, "text": "Confirmatory: \u226510% and \u226515% weight loss at week 68; baseline-to-week-68 change in waist circumference, systolic blood pressure, SF-36 physical functioning and IWQOL-Lite-CT physical function. Supportive: \u226520% loss; weight (kg), BMI, diastolic pressure, lipids, CRP, PAI-1, other SF-36/IWQOL scores and physical-function responders, HbA1c, fasting glucose/insulin, leptin and soluble leptin receptor, and DEXA body composition/weight. Safety: TEAEs/SAEs through week 75 and pulse, amylase, lipase, calcitonin change to week 68. [CSR PDF pp. 59-61; Table 9-8]" }, { "id": "1215263892", "alias": "Included studies \u2014 Study 1 exploratory endpoints", "group": "Included studies", "state": "answered", "chars": 326, "cited_pages": [ 61 ], "sentence_checks": [ { "cited": 61, "best": 15, "score": 2, "delta": 46 } ], "numbers": {}, "bracket_cites": 1, "text": "Baseline-to-week-68 glycaemic category, antihypertensive/lipid-lowering medication change, SPS-6 total, fatty liver index category, ICIQ-UI-SF in women; permanent product discontinuation and time to discontinuation through week 68; food diary days and physical activity minutes/week through week 68. [CSR PDF p. 61; Table 9-8]" }, { "id": "1730012574", "alias": "Included studies \u2014 Study 2 secondary endpoints", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "606880433", "alias": "Included studies \u2014 Study 2 exploratory endpoints", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1856749314", "alias": "Included studies \u2014 Study 1 publications", "group": "Included studies", "state": "answered", "chars": 179, "cited_pages": [ 1, 2 ], "sentence_checks": [ { "cited": 1, "best": 1, "score": 3, "delta": 0 } ], "numbers": { "1.0": "on_cited_page", "4373": "on_cited_page", "2020": "on_cited_page" }, "bracket_cites": 1, "text": "Novo Nordisk. NN9536-4373 (STEP 1), clinical trial report, final version 1.0, 17 August 2020. [CSR PDF pp. 1-2] No STEP 1 journal publication is identified in the supplied report." }, { "id": "563167750", "alias": "Included studies \u2014 Study 1 ClinicalTrials.gov entry", "group": "Included studies", "state": "answered", "chars": 58, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "ClinicalTrials.gov identifier: NCT03548935. [CSR PDF p. 2]" }, { "id": "815883534", "alias": "Included studies \u2014 Study 2 publications", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "386404186", "alias": "Included studies \u2014 Study 2 ClinicalTrials.gov entry", "group": "Included studies", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1444027236", "alias": "Long-term extension \u2014 description of studies", "group": "Long-term extension", "state": "answered", "chars": 119, "cited_pages": [ 1, 2 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Included evidence: one supplied CSR for STEP 1; this is not a completed systematic literature review. [CSR PDF pp. 1-2]" }, { "id": "1994106587", "alias": "Systematic review \u2014 description of included studies", "group": "Systematic review", "state": "answered", "chars": 1227, "cited_pages": [ 2, 33, 42, 65 ], "sentence_checks": [ { "cited": 33, "best": 60, "score": 9, "delta": 27 }, { "cited": 2, "best": 28, "score": 11, "delta": 26 } ], "numbers": { "1306": "on_cited_page", "2.4": "on_cited_page", "1961": "on_cited_page", "129": "on_cited_page", "655": "on_cited_page", "2020": "on_cited_page" }, "bracket_cites": 7, "text": "Trial objective: compare semaglutide 2.4 mg weekly versus placebo, adjunctive to diet/activity, for weight loss, efficacy and safety in adults with overweight or obesity. [CSR PDF p. 33] A systematic-review objective/protocol is not supplied. STEP 1 compared semaglutide 2.4 mg weekly with placebo, each with lifestyle intervention, for body weight, cardiovascular risk factors, clinical outcome assessments, glucose metabolism, other weight-related factors, safety and tolerability. [CSR PDF p. 33] A systematic-review protocol is not reported. Phase 3a, multicentre, multinational, randomised (2:1)" }, { "id": "827021544", "alias": "Systematic review \u2014 eligibility criteria discussion", "group": "Systematic review", "state": "answered", "chars": 942, "cited_pages": [ 36, 37, 38 ], "sentence_checks": [ { "cited": 37, "best": 37, "score": 6, "delta": 0 }, { "cited": 37, "best": 209, "score": 3, "delta": 172 } ], "numbers": { "6.5%": "on_cited_page", "180": "elsewhere" }, "bracket_cites": 3, "text": "Adults \u226518 years with BMI \u226530 kg/m\u00b2, or \u226527 kg/m\u00b2 with \u22651 treated or untreated weight-related comorbidity (hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease), and \u22651 self-reported unsuccessful dietary weight-loss effort. [CSR PDF p. 37] Diabetes was excluded; the separate STEP 2 trial was intended to address people with type 2 diabetes. [CSR PDF p. 36] Key exclusions: HbA1c \u22656.5%; weight change >5 kg within 90 days; history of type 1/type 2 diabetes; uncontrolled thyroid disease; severe psychiatric disorders/major depression and suicidality criteria; pregnancy/" }, { "id": "680657803", "alias": "Systematic review \u2014 interventions", "group": "Systematic review", "state": "answered", "chars": 1159, "cited_pages": [ 38, 39, 40, 41, 42, 43, 44 ], "sentence_checks": [ { "cited": 39, "best": 61, "score": 2, "delta": 22 } ], "numbers": { "100": "on_cited_page", "0.25": "on_cited_page", "2.4": "on_cited_page", "500": "on_cited_page", "0.5": "on_cited_page", "150": "on_cited_page", "1.0": "on_cited_page", "1.7": "on_cited_page" }, "bracket_cites": 4, "text": "Trial regimen: 0.25 mg once weekly for 4 weeks, then 0.5, 1.0 and 1.7 mg once weekly for 4 weeks each, then 2.4 mg once weekly for 52 weeks (68 weeks total). If 2.4 mg was not tolerated, 1.7 mg was permitted to avoid complete discontinuation, with an attempt to re-escalate recommended. [CSR PDF pp. 39-40; Tables 9-1 and 9-2] Matched placebo injection once weekly using the same pen and escalating volumes for 68 weeks; both groups received diet counselling targeting a 500 kcal/day deficit and \u2265150 minutes/week physical activity, with counselling every 4 weeks. [CSR PDF pp. 39-42] Products were i" }, { "id": "1379685635", "alias": "Systematic review \u2014 outcome measures", "group": "Systematic review", "state": "answered", "chars": 1738, "cited_pages": [ 45, 46, 49, 50, 51, 52, 53, 54, 59, 60, 61 ], "sentence_checks": [ { "cited": 45, "best": 45, "score": 5, "delta": 0 }, { "cited": 59, "best": 125, "score": 10, "delta": 66 } ], "numbers": { "68,": "on_cited_page", "100": "elsewhere", "5%": "on_cited_page", "20%": "on_cited_page", "50,": "on_cited_page", "4.3": "on_cited_page", "15%": "on_cited_page", "10%": "on_cited_page" }, "bracket_cites": 5, "text": "Baseline efficacy assessments were at randomisation unless specified. Weight used a calibrated digital scale, without shoes, with empty bladder and light clothing; BMI was calculated from weight and height; waist was measured midway between lower rib and iliac crest. [CSR PDF p. 45] Change in body weight (%) from week 0 to week 68, and achieving \u22655% baseline body-weight reduction at week 68. [CSR PDF p. 59; Table 9-8] Confirmatory: \u226510% and \u226515% weight loss at week 68; baseline-to-week-68 change in waist circumference, systolic blood pressure, SF-36 physical functioning and IWQOL-Lite-CT physi" }, { "id": "31726976", "alias": "Summary of outcomes table \u2014 number", "group": "Summary of outcomes table", "state": "answered", "chars": 1, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "4" }, { "id": "1043302581", "alias": "Summary of outcomes \u2014 outcome 1 measure", "group": "Summary of outcomes", "state": "answered", "chars": 137, "cited_pages": [ 59 ], "sentence_checks": [], "numbers": { "68,": "on_cited_page", "5%": "on_cited_page" }, "bracket_cites": 1, "text": "Change in body weight (%) from week 0 to week 68, and achieving \u22655% baseline body-weight reduction at week 68. [CSR PDF p. 59; Table 9-8]" }, { "id": "1472210191", "alias": "Summary of outcomes \u2014 outcome 1 timepoint", "group": "Summary of outcomes", "state": "answered", "chars": 38, "cited_pages": [ 59 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Week 68 versus week 0. [CSR PDF p. 59]" }, { "id": "1842122795", "alias": "Summary of outcomes \u2014 Study 1 outcome 1 classification", "group": "Summary of outcomes", "state": "answered", "chars": 83, "cited_pages": [ 34 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Co-primary*; multiplicity-controlled treatment-policy analyses. [CSR PDF pp. 34,87]" }, { "id": "1307588923", "alias": "Summary of outcomes \u2014 Study 2 outcome 1 classification", "group": "Summary of outcomes", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "266798436", "alias": "Summary of outcomes \u2014 outcome 2 measure", "group": "Summary of outcomes", "state": "answered", "chars": 884, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [ { "cited": 59, "best": 125, "score": 10, "delta": 66 }, { "cited": 61, "best": 15, "score": 2, "delta": 46 } ], "numbers": { "20%": "on_cited_page", "15%": "on_cited_page", "10%": "on_cited_page" }, "bracket_cites": 2, "text": "Confirmatory: \u226510% and \u226515% weight loss at week 68; baseline-to-week-68 change in waist circumference, systolic blood pressure, SF-36 physical functioning and IWQOL-Lite-CT physical function. Supportive: \u226520% loss; weight (kg), BMI, diastolic pressure, lipids, CRP, PAI-1, other SF-36/IWQOL scores and physical-function responders, HbA1c, fasting glucose/insulin, leptin and soluble leptin receptor, and DEXA body composition/weight. Safety: TEAEs/SAEs through week 75 and pulse, amylase, lipase, calcitonin change to week 68. [CSR PDF pp. 59-61; Table 9-8] Baseline-to-week-68 glycaemic category, an" }, { "id": "1438797414", "alias": "Summary of outcomes \u2014 outcome 2 timepoint", "group": "Summary of outcomes", "state": "answered", "chars": 57, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Week 68 efficacy; week 75 TEAEs/SAEs. [CSR PDF pp. 59-61]" }, { "id": "504497766", "alias": "Summary of outcomes \u2014 Study 1 outcome 2 classification", "group": "Summary of outcomes", "state": "answered", "chars": 172, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Confirmatory secondary* and supportive secondary/exploratory as specified in this row; * hierarchical testing applies only to confirmatory endpoints. [CSR PDF pp. 59-61,87]" }, { "id": "1872620584", "alias": "Summary of outcomes \u2014 Study 2 outcome 2 classification", "group": "Summary of outcomes", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "24624863", "alias": "Systematic review \u2014 clinical endpoint statistical analysis", "group": "Systematic review", "state": "answered", "chars": 1517, "cited_pages": [ 33, 34, 35, 36, 92, 441, 442, 443 ], "sentence_checks": [], "numbers": { "-30%": "on_cited_page", "5%": "on_cited_page", "0.3": "on_cited_page", "1%": "on_cited_page", "1000": "on_cited_page", "30%": "on_cited_page" }, "bracket_cites": 4, "text": "Primary treatment-policy estimand uses all randomised subjects regardless of treatment interruptions/discontinuation or other anti-obesity therapy. Week-68 continuous outcomes use ANCOVA with randomised treatment and baseline endpoint covariate; weight-loss responder outcomes use logistic regression with treatment and baseline body weight. Missing values undergo 1000 multiple imputations from retrieved participants in the same arm, grouped using timing of last on-treatment observation. This assumes missing participants resemble the corresponding retrieved participants conditional on imputation" }, { "id": "1343303465", "alias": "Statistical analysis table \u2014 number", "group": "Statistical analysis table", "state": "answered", "chars": 1, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "5" }, { "id": "1961702415", "alias": "Statistical analysis \u2014 Study 1 endpoint 1", "group": "Statistical analysis", "state": "answered", "chars": 137, "cited_pages": [ 59 ], "sentence_checks": [], "numbers": { "68,": "on_cited_page", "5%": "on_cited_page" }, "bracket_cites": 1, "text": "Change in body weight (%) from week 0 to week 68, and achieving \u22655% baseline body-weight reduction at week 68. [CSR PDF p. 59; Table 9-8]" }, { "id": "2143684928", "alias": "Statistical analysis \u2014 Study 1 endpoint 1 model", "group": "Statistical analysis", "state": "answered", "chars": 102, "cited_pages": [ 93 ], "sentence_checks": [], "numbers": { "5%": "on_cited_page" }, "bracket_cites": 1, "text": "ANCOVA for percentage weight change; binary logistic regression for \u22655% response. [CSR PDF pp. 93,333]" }, { "id": "1331195698", "alias": "Statistical analysis \u2014 Study 1 endpoint 1 adjustment factors", "group": "Statistical analysis", "state": "answered", "chars": 73, "cited_pages": [ 93 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Treatment factor and baseline body-weight covariate. [CSR PDF pp. 93,333]" }, { "id": "1125550508", "alias": "Statistical analysis \u2014 Study 1 endpoint 1 missing data", "group": "Statistical analysis", "state": "answered", "chars": 149, "cited_pages": [ 62 ], "sentence_checks": [], "numbers": { "1000": "elsewhere" }, "bracket_cites": 1, "text": "1000 retrieved-participant multiple imputations within treatment arm; timing of last on-treatment observation informs groups. [CSR PDF pp. 62,93,333]" }, { "id": "118805113", "alias": "Statistical analysis \u2014 Study 1 endpoint 1 sensitivity analyses", "group": "Statistical analysis", "state": "answered", "chars": 399, "cited_pages": [ 92 ], "sentence_checks": [], "numbers": { "-30%": "on_cited_page", "5%": "on_cited_page", "0.3": "elsewhere", "1%": "on_cited_page", "1000": "elsewhere", "30%": "on_cited_page" }, "bracket_cites": 1, "text": "Sensitivity analyses: jump-to-reference imputation from placebo (1000 imputations); single imputation adding 0.3 kg/month regain to last value until baseline, for both arms or semaglutide only; MMRM. The \u22655% responder analysis also treats missing responses as nonresponders. Two-way tipping-point penalties ranged -30% to +30% in 1% steps without overturning superiority. [CSR PDF pp. 92,94,334,346]" }, { "id": "932791655", "alias": "Statistical analysis \u2014 Study 1 additional endpoints", "group": "Statistical analysis", "state": "answered", "chars": 557, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [ { "cited": 59, "best": 125, "score": 10, "delta": 66 } ], "numbers": { "20%": "on_cited_page", "15%": "on_cited_page", "10%": "on_cited_page" }, "bracket_cites": 1, "text": "Confirmatory: \u226510% and \u226515% weight loss at week 68; baseline-to-week-68 change in waist circumference, systolic blood pressure, SF-36 physical functioning and IWQOL-Lite-CT physical function. Supportive: \u226520% loss; weight (kg), BMI, diastolic pressure, lipids, CRP, PAI-1, other SF-36/IWQOL scores and physical-function responders, HbA1c, fasting glucose/insulin, leptin and soluble leptin receptor, and DEXA body composition/weight. Safety: TEAEs/SAEs through week 75 and pulse, amylase, lipase, calcitonin change to week 68. [CSR PDF pp. 59-61; Table 9-8]" }, { "id": "724079627", "alias": "Statistical analysis \u2014 Study 1 additional endpoint models", "group": "Statistical analysis", "state": "answered", "chars": 86, "cited_pages": [ 362 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Continuous: ANCOVA; binary: logistic regression. [CSR PDF pp. 362,371,400,418,462,488]" }, { "id": "1063602554", "alias": "Statistical analysis \u2014 Study 1 additional endpoint adjustment factors", "group": "Statistical analysis", "state": "answered", "chars": 128, "cited_pages": [ 362 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Treatment and corresponding baseline value; baseline body weight for weight-loss response. [CSR PDF pp. 362,371,400,418,462,488]" }, { "id": "1996243408", "alias": "Statistical analysis \u2014 Study 1 additional endpoint missing data", "group": "Statistical analysis", "state": "answered", "chars": 126, "cited_pages": [ 371 ], "sentence_checks": [], "numbers": { "1000": "on_cited_page" }, "bracket_cites": 1, "text": "Retrieved-participant multiple imputation (1000 datasets) for confirmatory continuous endpoints. [CSR PDF pp. 371,418,462,488]" }, { "id": "1507612720", "alias": "Statistical analysis \u2014 Study 1 additional endpoint sensitivity analyses", "group": "Statistical analysis", "state": "answered", "chars": 158, "cited_pages": [ 97 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Jump-to-reference sensitivity analyses for confirmatory continuous outcomes; hypothetical MMRM as complementary estimand. [CSR PDF pp. 97,107,113-114,117-119]" }, { "id": "1193492575", "alias": "Statistical analysis \u2014 Study 2 endpoints", "group": "Statistical analysis", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "598107064", "alias": "Statistical analysis \u2014 Study 2 endpoint models", "group": "Statistical analysis", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1962817948", "alias": "Statistical analysis \u2014 Study 2 endpoint adjustment factors", "group": "Statistical analysis", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "839539422", "alias": "Statistical analysis \u2014 Study 2 endpoint sensitivity analyses", "group": "Statistical analysis", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1518305444", "alias": "Systematic review \u2014 sample size and power calculation", "group": "Systematic review", "state": "answered", "chars": 424, "cited_pages": [ 36 ], "sentence_checks": [], "numbers": { "4233": "elsewhere", "99%": "on_cited_page", "4153": "elsewhere", "650": "on_cited_page", "1950": "on_cited_page", "1300": "on_cited_page" }, "bracket_cites": 1, "text": "Planned N=1950 (1300 semaglutide, 650 placebo), driven by safety exposure/regulatory requirements; effective power 99% for the eight hierarchical efficacy endpoints. SAP updated IWQOL physical-function power using trials NN9536-4153 and NN9924-4233 without changing N. [CSR PDF pp. 36,62] Numeric effect/SD/dropout assumptions are not reproduced in the supplied report; it refers to protocol/SAP appendices for calculations." }, { "id": "959984345", "alias": "Systematic review \u2014 statistical testing", "group": "Systematic review", "state": "answered", "chars": 1485, "cited_pages": [ 33, 34, 35, 36 ], "sentence_checks": [ { "cited": 34, "best": 125, "score": 6, "delta": 91 } ], "numbers": { "5%": "on_cited_page", "15%": "elsewhere", "10%": "on_cited_page", "0.05": "elsewhere", "1000": "elsewhere" }, "bracket_cites": 3, "text": "Superiority trial; confirmatory treatment-policy testing used a prespecified hierarchy: percentage weight change, \u22655%, \u226510%, \u226515% weight-loss response, waist circumference, systolic blood pressure, SF-36 physical functioning, IWQOL physical function. Local two-sided alpha was 0.05 at each reached test, with family-wise error controlled by the hierarchy; reported p-values are unadjusted two-sided values. All eight tests passed. Final main-phase analyses; no interim or post-hoc analyses were performed. [CSR PDF pp. 34-36,63,87] Primary treatment-policy estimand uses all randomised subjects regar" }, { "id": "1484745767", "alias": "Systematic review \u2014 subgroup analyses", "group": "Systematic review", "state": "answered", "chars": 245, "cited_pages": [ 35 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No treatment-by-subgroup efficacy analyses, subgroup multiplicity adjustment or subgroup interaction tests are reported in the supplied CSR. DEXA was a prespecified subpopulation (acceptable screening scan, BMI \u226440 kg/m\u00b2). [CSR PDF pp. 35,38,58]" }, { "id": "61317614", "alias": "Systematic review \u2014 analysis populations", "group": "Systematic review", "state": "answered", "chars": 176, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": { "1961": "elsewhere" }, "bracket_cites": 1, "text": "Analysis sets were defined before unblinding: FAS, SAS and DEXA. All 1961 randomised participants were exposed, so FAS and SAS contained the same people. [CSR PDF pp. 58,65-66]" }, { "id": "463215069", "alias": "Analysis populations table \u2014 number", "group": "Analysis populations table", "state": "answered", "chars": 1, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "6" }, { "id": "804780957", "alias": "Analysis populations \u2014 Study 1 full analysis set", "group": "Analysis populations", "state": "answered", "chars": 19, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "FAS [CSR PDF p. 58]" }, { "id": "595102914", "alias": "Analysis populations \u2014 Study 1 full analysis set definition", "group": "Analysis populations", "state": "answered", "chars": 104, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": { "1306": "elsewhere", "655": "elsewhere" }, "bracket_cites": 1, "text": "All randomised participants, evaluated as randomised: 1306 semaglutide; 655 placebo. [CSR PDF pp. 58,65]" }, { "id": "20935121", "alias": "Analysis populations \u2014 Study 1 full analysis set application", "group": "Analysis populations", "state": "answered", "chars": 64, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Efficacy analyses and baseline summaries. [CSR PDF pp. 58,68-70]" }, { "id": "1188062953", "alias": "Analysis populations \u2014 Study 1 safety analysis set", "group": "Analysis populations", "state": "answered", "chars": 19, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "SAS [CSR PDF p. 58]" }, { "id": "157934274", "alias": "Analysis populations \u2014 Study 1 safety analysis set definition", "group": "Analysis populations", "state": "answered", "chars": 119, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": { "1306": "elsewhere", "655": "elsewhere" }, "bracket_cites": 1, "text": "All randomised participants receiving \u22651 dose, evaluated as treated: 1306 semaglutide; 655 placebo. [CSR PDF pp. 58,65]" }, { "id": "2139934214", "alias": "Analysis populations \u2014 Study 1 safety analysis set application", "group": "Analysis populations", "state": "answered", "chars": 41, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Safety analyses. [CSR PDF pp. 58,127-129]" }, { "id": "1011405707", "alias": "Analysis populations \u2014 Study 1 additional populations", "group": "Analysis populations", "state": "answered", "chars": 33, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "DEXA analysis set [CSR PDF p. 58]" }, { "id": "946264035", "alias": "Analysis populations \u2014 Study 1 additional population definitions", "group": "Analysis populations", "state": "answered", "chars": 113, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": { "140": "elsewhere" }, "bracket_cites": 1, "text": "FAS subset with acceptable baseline DEXA scan: 140 participants (95 semaglutide, 45 placebo). [CSR PDF pp. 58,72]" }, { "id": "888751945", "alias": "Analysis populations \u2014 Study 1 additional population applications", "group": "Analysis populations", "state": "answered", "chars": 51, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Body-composition analyses. [CSR PDF pp. 58,102-103]" }, { "id": "1360195625", "alias": "Analysis populations \u2014 Study 2 populations", "group": "Analysis populations", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1729002899", "alias": "Analysis populations \u2014 Study 2 population definitions", "group": "Analysis populations", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1469609859", "alias": "Analysis populations \u2014 Study 2 population applications", "group": "Analysis populations", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1326250245", "alias": "Baseline characteristics table \u2014 number", "group": "Baseline characteristics table", "state": "answered", "chars": 1, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "7" }, { "id": "102045275", "alias": "Baseline characteristics \u2014 Study 1 treatment 1", "group": "Baseline characteristics", "state": "answered", "chars": 34, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "2.4": "on_cited_page" }, "bracket_cites": 1, "text": "Semaglutide 2.4 mg [CSR PDF p. 65]" }, { "id": "1512625313", "alias": "Baseline characteristics \u2014 Study 1 treatment 1 sample size", "group": "Baseline characteristics", "state": "answered", "chars": 20, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "1306": "on_cited_page" }, "bracket_cites": 1, "text": "1306 [CSR PDF p. 65]" }, { "id": "1591733779", "alias": "Baseline characteristics \u2014 Study 1 treatment 2", "group": "Baseline characteristics", "state": "answered", "chars": 23, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Placebo [CSR PDF p. 65]" }, { "id": "1736481156", "alias": "Baseline characteristics \u2014 Study 1 treatment 2 sample size", "group": "Baseline characteristics", "state": "answered", "chars": 19, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "655": "on_cited_page" }, "bracket_cites": 1, "text": "655 [CSR PDF p. 65]" }, { "id": "193741279", "alias": "Baseline characteristics \u2014 Study 2 treatment 1", "group": "Baseline characteristics", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "111637051", "alias": "Baseline characteristics \u2014 Study 2 treatment 1 sample size", "group": "Baseline characteristics", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "631428389", "alias": "Baseline characteristics \u2014 Study 2 treatment 2", "group": "Baseline characteristics", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1625834215", "alias": "Baseline characteristics \u2014 Study 2 treatment 2 sample size", "group": "Baseline characteristics", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "2073310631", "alias": "Baseline characteristics \u2014 row 1 characteristic", "group": "Baseline characteristics", "state": "answered", "chars": 20, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Age; sex; race (FAS)" }, { "id": "1668943772", "alias": "Baseline characteristics \u2014 row 1 Study 1 treatment 1 result", "group": "Baseline characteristics", "state": "answered", "chars": 158, "cited_pages": [ 69, 70 ], "sentence_checks": [], "numbers": { "973": "on_cited_page", "955": "on_cited_page", "73.1%": "on_cited_page", "46,": "on_cited_page", "74.5%": "on_cited_page", "13.9%": "on_cited_page", "181": "on_cited_page", "5.5%": "on_cited_page" }, "bracket_cites": 1, "text": "Age 46 (SD 13) years; median 46, range 18-86. Female 955 (73.1%); White 973 (74.5%); Asian 181 (13.9%); Black 72 (5.5%). [CSR PDF pp. 69-70; Tables 10-2/10-3]" }, { "id": "1380477065", "alias": "Baseline characteristics \u2014 row 1 Study 1 treatment 2 result", "group": "Baseline characteristics", "state": "answered", "chars": 157, "cited_pages": [ 69, 70 ], "sentence_checks": [], "numbers": { "48,": "on_cited_page", "498": "on_cited_page", "499": "on_cited_page", "76.0%": "on_cited_page", "12.2%": "on_cited_page", "6.0%": "on_cited_page", "76.2%": "on_cited_page" }, "bracket_cites": 1, "text": "Age 47 (SD 12) years; median 48, range 18-82. Female 498 (76.0%); White 499 (76.2%); Asian 80 (12.2%); Black 39 (6.0%). [CSR PDF pp. 69-70; Tables 10-2/10-3]" }, { "id": "985240144", "alias": "Baseline characteristics \u2014 row 1 Study 2 treatment 1 result", "group": "Baseline characteristics", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1015840200", "alias": "Baseline characteristics \u2014 row 1 Study 2 treatment 2 result", "group": "Baseline characteristics", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "117772731", "alias": "Baseline characteristics \u2014 row 2 characteristic", "group": "Baseline characteristics", "state": "answered", "chars": 35, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Weight; BMI; waist (FAS), mean (SD)" }, { "id": "2081112730", "alias": "Baseline characteristics \u2014 row 2 Study 1 treatment 1 result", "group": "Baseline characteristics", "state": "answered", "chars": 141, "cited_pages": [ 70 ], "sentence_checks": [], "numbers": { "6.7": "on_cited_page", "114.6": "on_cited_page", "22.1": "on_cited_page", "245.6": "on_cited_page", "102.1": "on_cited_page", "37.8": "on_cited_page", "61.8": "on_cited_page", "105.4": "on_cited_page", "1306": "on_cited_page", "14.8": "on_cited_page" }, "bracket_cites": 1, "text": "Weight 105.4 (22.1) kg; median 102.1, range 61.8-245.6. BMI 37.8 (6.7) kg/m\u00b2; waist 114.6 (14.8) cm; n=1306 each. [CSR PDF p. 70; Table 10-3]" }, { "id": "1407604333", "alias": "Baseline characteristics \u2014 row 2 Study 1 treatment 2 result", "group": "Baseline characteristics", "state": "answered", "chars": 140, "cited_pages": [ 70 ], "sentence_checks": [], "numbers": { "14.4": "on_cited_page", "105.2": "on_cited_page", "114.8": "on_cited_page", "66.3": "on_cited_page", "21.5": "on_cited_page", "38.0": "on_cited_page", "101.3": "on_cited_page", "6.5": "on_cited_page", "655": "on_cited_page", "211.0": "on_cited_page" }, "bracket_cites": 1, "text": "Weight 105.2 (21.5) kg; median 101.3, range 66.3-211.0. BMI 38.0 (6.5) kg/m\u00b2; waist 114.8 (14.4) cm; n=655 each. [CSR PDF p. 70; Table 10-3]" }, { "id": "95831809", "alias": "Baseline characteristics \u2014 row 2 Study 2 treatment 1 result", "group": "Baseline characteristics", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "438525311", "alias": "Baseline characteristics \u2014 row 2 Study 2 treatment 2 result", "group": "Baseline characteristics", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1742127148", "alias": "Baseline characteristics \u2014 row 3 characteristic", "group": "Baseline characteristics", "state": "answered", "chars": 31, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Glycaemia and comorbidity (FAS)" }, { "id": "1933230921", "alias": "Baseline characteristics \u2014 row 3 Study 1 treatment 1 result", "group": "Baseline characteristics", "state": "answered", "chars": 255, "cited_pages": [ 68, 71 ], "sentence_checks": [ { "cited": 71, "best": 71, "score": 2, "delta": 0 } ], "numbers": { "45%": "on_cited_page", "11.7%": "on_cited_page", "5.3": "on_cited_page", "1291": "elsewhere", "5.7": "on_cited_page", "37.0%": "on_cited_page", "14.0%": "on_cited_page", "0.6": "on_cited_page", "0.3": "elsewhere", "36.0%": "on_cited_page", "1306": "elsewhere" }, "bracket_cites": 2, "text": "HbA1c 5.7 (0.3)%, n=1306; fasting glucose 5.3 (0.6) mmol/L, n=1291 (15 missing). Prediabetes approximately 45%. [CSR PDF pp. 68,70] Overall population: dyslipidaemia 37.0%, hypertension 36.0%, knee osteoarthritis 14.0%, sleep apnoea 11.7%. [CSR PDF p. 71]" }, { "id": "1975591537", "alias": "Baseline characteristics \u2014 row 3 Study 1 treatment 2 result", "group": "Baseline characteristics", "state": "answered", "chars": 195, "cited_pages": [ 68, 71 ], "sentence_checks": [], "numbers": { "5.3": "on_cited_page", "40%": "on_cited_page", "649": "elsewhere", "5.7": "on_cited_page", "0.6": "on_cited_page", "0.3": "elsewhere", "655": "elsewhere" }, "bracket_cites": 2, "text": "HbA1c 5.7 (0.3)%, n=655; fasting glucose 5.3 (0.6) mmol/L, n=649 (6 missing). Prediabetes approximately 40%. [CSR PDF pp. 68,70] Comorbidity proportions were similar between arms. 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[CSR PDF pp. 68,209]" }, { "id": "48742338", "alias": "Patient disposition \u2014 screening failure reason 1 \u2014 Study 1 treatment 2", "group": "Patient disposition", "state": "answered", "chars": 79, "cited_pages": [ 68 ], "sentence_checks": [], "numbers": { "305": "on_cited_page", "39.3%": "on_cited_page", "120": "on_cited_page" }, "bracket_cites": 1, "text": "120/305 screen failures (39.3%), pooled before allocation. [CSR PDF pp. 68,209]" }, { "id": "1193397786", "alias": "Patient disposition \u2014 screening failure reason 1 \u2014 Study 2 treatment 1", "group": "Patient disposition", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1891649972", "alias": "Patient disposition \u2014 screening failure reason 1 \u2014 Study 2 treatment 2", "group": "Patient disposition", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1088696735", "alias": "Patient disposition \u2014 screening failure reason 2", "group": "Patient disposition", "state": "answered", "chars": 28, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Uncontrolled thyroid disease" }, { "id": "2023407013", "alias": "Patient disposition \u2014 screening failure reason 2 \u2014 Study 1 treatment 1", "group": "Patient disposition", "state": "answered", "chars": 62, "cited_pages": [ 68 ], "sentence_checks": [], "numbers": { "305": "on_cited_page", "26.6%": "on_cited_page" }, "bracket_cites": 1, "text": "81/305 (26.6%), pooled before allocation. 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[CSR PDF p. 1]" }, { "id": "161622868", "alias": "Patient disposition \u2014 discontinued from study \u2014 Study 2 treatment 2", "group": "Patient disposition", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1330433526", "alias": "Patient disposition \u2014 discontinuation due to adverse events \u2014 Study 1 treatment 1", "group": "Patient disposition", "state": "answered", "chars": 155, "cited_pages": [ 136, 137 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "4 consent withdrawals mentioning AEs, plus 1 death; not systematically collected; primary disposition category is not AE. 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[CSR PDF p. 1]" }, { "id": "621664135", "alias": "Patient disposition \u2014 safety \u2014 Study 1 treatment 1", "group": "Patient disposition", "state": "answered", "chars": 36, "cited_pages": [ 65, 66 ], "sentence_checks": [], "numbers": { "1306": "on_cited_page" }, "bracket_cites": 1, "text": "1306 [CSR PDF pp. 65-66; Table 10-1]" }, { "id": "344799928", "alias": "Patient disposition \u2014 safety \u2014 Study 1 treatment 2", "group": "Patient disposition", "state": "answered", "chars": 35, "cited_pages": [ 65, 66 ], "sentence_checks": [], "numbers": { "655": "on_cited_page" }, "bracket_cites": 1, "text": "655 [CSR PDF pp. 65-66; Table 10-1]" }, { "id": "272364580", "alias": "Patient disposition \u2014 safety \u2014 Study 2 treatment 1", "group": "Patient disposition", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1044293921", "alias": "Patient disposition \u2014 safety \u2014 Study 2 treatment 2", "group": "Patient disposition", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "379272513", "alias": "Exposure to interventions \u2014 study treatments narrative", "group": "Exposure to interventions", "state": "answered", "chars": 468, "cited_pages": [ 58, 73, 74 ], "sentence_checks": [], "numbers": { "1480.8": "on_cited_page", "59.2": "on_cited_page", "1706.1": "elsewhere", "829.6": "elsewhere", "720.9": "on_cited_page", "98.0%": "on_cited_page", "89.6%": "on_cited_page", "57.4": "on_cited_page" }, "bracket_cites": 2, "text": "Mean on-treatment exposure was 59.2 versus 57.4 weeks; total exposure 1480.8 versus 720.9 patient-years (semaglutide versus placebo). This efficacy observation definition differs from the +7-week AE exposure window (1706.1 versus 829.6 patient-years). [CSR PDF pp. 58,73,128] At last dose, 89.6% versus 98.0% of treatment completers reached maintenance dose/equivalent placebo volume. Compliance was assessed by missed-dose questioning and diaries. [CSR PDF pp. 73-74]" }, { "id": "1129376544", "alias": "Patient exposure table \u2014 number", "group": "Patient exposure table", "state": "answered", "chars": 1, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "9" }, { "id": "999719648", "alias": "Patient exposure \u2014 Study 1 treatment 1", "group": "Patient exposure", "state": "answered", "chars": 34, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "2.4": "on_cited_page" }, "bracket_cites": 1, "text": "Semaglutide 2.4 mg [CSR PDF p. 65]" }, { "id": "1566511647", "alias": "Patient exposure \u2014 Study 1 treatment 1 sample size", "group": "Patient exposure", "state": "answered", "chars": 20, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "1306": "on_cited_page" }, "bracket_cites": 1, "text": "1306 [CSR PDF p. 65]" }, { "id": "849608264", "alias": "Patient exposure \u2014 Study 1 treatment 2", "group": "Patient exposure", "state": "answered", "chars": 23, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Placebo [CSR PDF p. 65]" }, { "id": "1311852991", "alias": "Patient exposure \u2014 Study 1 treatment 2 sample size", "group": "Patient exposure", "state": "answered", "chars": 19, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "655": "on_cited_page" }, "bracket_cites": 1, "text": "655 [CSR PDF p. 65]" }, { "id": "323615679", "alias": "Patient exposure \u2014 Study 2 treatment 1", "group": "Patient exposure", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1312152643", "alias": "Patient exposure \u2014 Study 2 treatment 1 sample size", "group": "Patient exposure", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1720307850", "alias": "Patient exposure \u2014 Study 2 treatment 2", "group": "Patient exposure", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1920971000", "alias": "Patient exposure \u2014 Study 2 treatment 2 sample size", "group": "Patient exposure", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1622255754", "alias": "Patient exposure \u2014 total exposure \u2014 Study 1 treatment 1", "group": "Patient exposure", "state": "answered", "chars": 139, "cited_pages": [ 310 ], "sentence_checks": [], "numbers": { "1480.8": "on_cited_page", "1570.0": "on_cited_page" }, "bracket_cites": 1, "text": "1480.8 patient-years to first discontinuation; 1570.0 including subsequent on-treatment periods (+14 days). [CSR PDF p. 310; Table 14.1.23]" }, { "id": "1676202065", "alias": "Patient exposure \u2014 total exposure \u2014 Study 1 treatment 2", "group": "Patient exposure", "state": "answered", "chars": 137, "cited_pages": [ 310 ], "sentence_checks": [], "numbers": { "763.1": "on_cited_page", "720.9": "on_cited_page" }, "bracket_cites": 1, "text": "720.9 patient-years to first discontinuation; 763.1 including subsequent on-treatment periods (+14 days). [CSR PDF p. 310; Table 14.1.23]" }, { "id": "207093970", "alias": "Patient exposure \u2014 total exposure \u2014 Study 2 treatment 1", "group": "Patient exposure", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. [CSR PDF p. 1]" }, { "id": "1600177533", "alias": "Patient exposure \u2014 total exposure \u2014 Study 2 treatment 2", "group": "Patient exposure", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. 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FAS n=1306/655; observed week-68 weight n=1212/577. [CSR PDF p. 333; Table 14.2.9] Observed week-68 \u22655% loss: 1047/1212 (86.4%) versus 182/577 (31.5%); adjusted treatment-policy OR 11.22 (95% CI 8.88-14.19), p<0.0001. Observed \u226510%, \u226515%, \u226520% responses were 69.1%, 50.5%, 32.0% versus 12.0%, 4.9%, 1.7%. 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[CSR PDF p. 87; Table 11-1]" }, { "id": "1310400713", "alias": "Key efficacy outcomes \u2014 Outcome 4 \u2014 reported result \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "answered", "chars": 83, "cited_pages": [ 41 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Placebo reference; both groups received lifestyle intervention. [CSR PDF pp. 41,87]" }, { "id": "1318587757", "alias": "Key efficacy outcomes \u2014 Outcome 4 \u2014 reported result \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "answered", "chars": 38, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No second study in CSR. 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[CSR PDF p. 1]" }, { "id": "2059624488", "alias": "Systematic review \u2014 efficacy outcome 1 heading", "group": "Systematic review", "state": "answered", "chars": 29, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Percentage body-weight change" }, { "id": "852036331", "alias": "Systematic review \u2014 efficacy outcome 1 narrative", "group": "Systematic review", "state": "answered", "chars": 545, "cited_pages": [ 90, 333 ], "sentence_checks": [], "numbers": { "68,": "on_cited_page", "-13.55": "on_cited_page", "-12.44": "on_cited_page", "-16.86%": "on_cited_page", "1306": "on_cited_page", "-14.85%": "on_cited_page", "-12.83": "elsewhere", "1212": "on_cited_page", "-2.41%": "on_cited_page", "577": "on_cited_page", "-2.44%": "on_cited_page", "95%": "on_cited_page", "-14.42": "on_cited_page", "-11.51": "on_cited_page", "-11.94": "elsewhere", "0.0001": "elsewhere", "655": "on_cited_page", "-13.37": "on_cited_page", "-15.29": "on_cited_page" }, "bracket_cites": 2, "text": "At week 68, treatment-policy estimated weight change was -14.85% with semaglutide and -2.41% with placebo: difference -12.44 percentage points (95% CI -13.37 to -11.51), p<0.0001. FAS n=1306/655; observed week-68 weight n=1212/577. [CSR PDF p. 333; Table 14.2.9] Hypothetical estimand: -16.86% versus -2.44%; difference -14.42 points (95% CI -15.29 to -13.55). Sensitivity differences ranged -11.94 to -12.83 points, all p<0.0001; tipping-point analysis did not overturn superiority over the examined penalty range. 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[CSR PDF p. 336]", "csr_pages_with_field_terms": 61 }, { "id": "1767344048", "alias": "Efficacy outcome sample \u2014 end-of-treatment value \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 44, "text": "102.72 kg; SE not reported. [CSR PDF p. 336]", "csr_pages_with_field_terms": 61 }, { "id": "1591601241", "alias": "Efficacy outcome sample \u2014 change from baseline \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 44, "text": "-15.33 kg; SE not reported. [CSR PDF p. 336]", "csr_pages_with_field_terms": 114 }, { "id": "267121885", "alias": "Efficacy outcome sample \u2014 change from baseline \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 43, "text": "-2.61 kg; SE not reported. [CSR PDF p. 336]", "csr_pages_with_field_terms": 114 }, { "id": "1759501106", "alias": "Efficacy outcome sample \u2014 difference versus control \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "answered", "chars": 52, "cited_pages": [ 336 ], "sentence_checks": [], "numbers": { "-11.74": "on_cited_page", "-13.68": "on_cited_page", "-12.71": "on_cited_page", "95%": "on_cited_page" }, "bracket_cites": 1, "text": "-12.71 kg (95% CI -13.68 to -11.74) [CSR PDF p. 336]" }, { "id": "79267020", "alias": "Efficacy outcome sample \u2014 difference versus control \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "answered", "chars": 37, "cited_pages": [ 336 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Reference comparator [CSR PDF p. 336]" }, { "id": "296249480", "alias": "Efficacy outcome sample \u2014 P value \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "answered", "chars": 71, "cited_pages": [ 336 ], "sentence_checks": [], "numbers": { "0.0001": "elsewhere" }, "bracket_cites": 1, "text": "<0.0001 (supportive; not in confirmatory hierarchy) [CSR PDF p. 336]" }, { "id": "1250120688", "alias": "Efficacy outcome sample \u2014 P value \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "answered", "chars": 37, "cited_pages": [ 336 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Reference comparator [CSR PDF p. 336]" }, { "id": "1413108311", "alias": "Efficacy outcome sample \u2014 dichotomous outcome name", "group": "Efficacy outcome sample", "state": "answered", "chars": 30, "cited_pages": [], "sentence_checks": [], "numbers": { "10%": "elsewhere" }, "bracket_cites": 0, "text": "\u226510% body-weight loss, week 68" }, { "id": "1314190250", "alias": "Efficacy outcome sample \u2014 n (%) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "answered", "chars": 43, "cited_pages": [ 344 ], "sentence_checks": [], "numbers": { "69.1%": "on_cited_page", "1212": "elsewhere", "838": "on_cited_page" }, "bracket_cites": 1, "text": "838/1212 (69.1%), observed [CSR PDF p. 344]" }, { "id": "1137967173", "alias": "Efficacy outcome sample \u2014 n (%) \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "answered", "chars": 41, "cited_pages": [ 344 ], "sentence_checks": [], "numbers": { "577": "elsewhere", "12.0%": "on_cited_page" }, "bracket_cites": 1, "text": "69/577 (12.0%), observed [CSR PDF p. 344]" }, { "id": "215140399", "alias": "Efficacy outcome sample \u2014 OR/RR (95% CI) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "answered", "chars": 45, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "14.68": "on_cited_page", "11.08": "on_cited_page", "19.44": "on_cited_page", "95%": "on_cited_page" }, "bracket_cites": 1, "text": "OR 14.68 (95% CI 11.08-19.44) [CSR PDF p. 87]" }, { "id": "709270625", "alias": "Efficacy outcome sample \u2014 OR/RR (95% CI) \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "answered", "chars": 36, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Reference comparator [CSR PDF p. 87]" }, { "id": "736057284", "alias": "Efficacy outcome sample \u2014 RD (95% CI) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 48, "text": "Risk difference/CI not reported. [CSR PDF p. 87]", "csr_pages_with_field_terms": 51 }, { "id": "1161887237", "alias": "Efficacy outcome sample \u2014 RD (95% CI) \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 48, "text": "Risk difference/CI not reported. [CSR PDF p. 87]", "csr_pages_with_field_terms": 51 }, { "id": "1615120398", "alias": "Efficacy outcome sample \u2014 P value (dichotomous) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "answered", "chars": 58, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "0.0001": "elsewhere", "0.05": "on_cited_page" }, "bracket_cites": 1, "text": "<0.0001; hierarchical test, alpha 0.05. [CSR PDF p. 87]" }, { "id": "2098439437", "alias": "Efficacy outcome sample \u2014 P value (dichotomous) \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "answered", "chars": 36, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Reference comparator [CSR PDF p. 87]" }, { "id": "1215509121", "alias": "Efficacy outcome sample \u2014 time-to-event outcome name", "group": "Efficacy outcome sample", "state": "answered", "chars": 48, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Overall survival (template time-to-event fields)" }, { "id": "2080988536", "alias": "Efficacy outcome sample \u2014 events n (%) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 100, "text": "Not reported: overall-survival efficacy analysis is not an endpoint in this CSR. [CSR PDF pp. 59-61]", "csr_pages_with_field_terms": 83 }, { "id": "24677705", "alias": "Efficacy outcome sample \u2014 events n (%) \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 100, "text": "Not reported: overall-survival efficacy analysis is not an endpoint in this CSR. [CSR PDF pp. 59-61]", "csr_pages_with_field_terms": 83 }, { "id": "2116625410", "alias": "Efficacy outcome sample \u2014 overall survival median \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 100, "text": "Not reported: overall-survival efficacy analysis is not an endpoint in this CSR. [CSR PDF pp. 59-61]", "csr_pages_with_field_terms": 63 }, { "id": "1107993731", "alias": "Efficacy outcome sample \u2014 overall survival median \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 100, "text": "Not reported: overall-survival efficacy analysis is not an endpoint in this CSR. [CSR PDF pp. 59-61]", "csr_pages_with_field_terms": 63 }, { "id": "110558745", "alias": "Efficacy outcome sample \u2014 HR (95% CI) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 100, "text": "Not reported: overall-survival efficacy analysis is not an endpoint in this CSR. [CSR PDF pp. 59-61]", "csr_pages_with_field_terms": 51 }, { "id": "639278874", "alias": "Efficacy outcome sample \u2014 HR (95% CI) \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 100, "text": "Not reported: overall-survival efficacy analysis is not an endpoint in this CSR. [CSR PDF pp. 59-61]", "csr_pages_with_field_terms": 51 }, { "id": "1940746162", "alias": "Efficacy outcome sample \u2014 P value (time-to-event) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 100, "text": "Not reported: overall-survival efficacy analysis is not an endpoint in this CSR. [CSR PDF pp. 59-61]", "csr_pages_with_field_terms": 58 }, { "id": "1296899676", "alias": "Efficacy outcome sample \u2014 P value (time-to-event) \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 100, "text": "Not reported: overall-survival efficacy analysis is not an endpoint in this CSR. [CSR PDF pp. 59-61]", "csr_pages_with_field_terms": 58 }, { "id": "1833050749", "alias": "Efficacy outcome sample \u2014 reporting month X", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 14, "text": "Not applicable", "csr_pages_with_field_terms": 20 }, { "id": "554703709", "alias": "Efficacy outcome sample \u2014 survival probability at X months \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 100, "text": "Not reported: overall-survival efficacy analysis is not an endpoint in this CSR. 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"numbers": {}, "bracket_cites": 0, "text": "Serious gastrointestinal disorders (SOC)" }, { "id": "437963654", "alias": "Systematic review \u2014 harms \u2014 SAE 1 \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 26, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": { "1.4%": "on_cited_page" }, "bracket_cites": 1, "text": "18 (1.4%) [CSR PDF p. 135]" }, { "id": "705322254", "alias": "Systematic review \u2014 harms \u2014 SAE 1 \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 18, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "0 [CSR PDF p. 135]" }, { "id": "1930814023", "alias": "Systematic review \u2014 harms \u2014 SAE 2 name", "group": "Systematic review", "state": "answered", "chars": 37, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Serious hepatobiliary disorders (SOC)" }, { "id": "1406392629", "alias": "Systematic review \u2014 harms \u2014 SAE 2 \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 26, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": { "1.3%": "on_cited_page" }, "bracket_cites": 1, "text": "17 (1.3%) [CSR PDF p. 135]" }, { "id": "2006320262", "alias": "Systematic review \u2014 harms \u2014 SAE 2 \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 25, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": { "0.2%": "on_cited_page" }, "bracket_cites": 1, "text": "1 (0.2%) [CSR PDF p. 135]" }, { "id": "1483521817", "alias": "Systematic review \u2014 harms \u2014 patients who stopped treatment \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 71, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "7.0%": "on_cited_page" }, "bracket_cites": 1, "text": "92 (7.0%); permanent product discontinuation, AE form. [CSR PDF p. 137]" }, { "id": "33425579", "alias": "Systematic review \u2014 harms \u2014 patients who stopped treatment \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 71, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "3.1%": "on_cited_page" }, "bracket_cites": 1, "text": "20 (3.1%); permanent product discontinuation, AE form. [CSR PDF p. 137]" }, { "id": "390444819", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 1 name", "group": "Systematic review", "state": "answered", "chars": 32, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Gastrointestinal disorders (SOC)" }, { "id": "360453968", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 1 \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 26, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "4.5%": "on_cited_page" }, "bracket_cites": 1, "text": "59 (4.5%) [CSR PDF p. 137]" }, { "id": "488266923", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 1 \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 25, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "0.8%": "on_cited_page" }, "bracket_cites": 1, "text": "5 (0.8%) [CSR PDF p. 137]" }, { "id": "80911201", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 2 name", "group": "Systematic review", "state": "answered", "chars": 27, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Psychiatric disorders (SOC)" }, { "id": "190329408", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 2 \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 25, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "0.5%": "on_cited_page" }, "bracket_cites": 1, "text": "7 (0.5%) [CSR PDF p. 137]" }, { "id": "1646255212", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 2 \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 25, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "0.5%": "on_cited_page" }, "bracket_cites": 1, "text": "3 (0.5%) [CSR PDF p. 137]" }, { "id": "721157853", "alias": "Systematic review \u2014 harms \u2014 patients who died \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 35, "cited_pages": [ 128 ], "sentence_checks": [], "numbers": { "0.1%": "on_cited_page" }, "bracket_cites": 1, "text": "1 (0.1%), in-trial [CSR PDF p. 128]" }, { "id": "1712975059", "alias": "Systematic review \u2014 harms \u2014 patients who died \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 35, "cited_pages": [ 128 ], "sentence_checks": [], "numbers": { "0.2%": "on_cited_page" }, "bracket_cites": 1, "text": "1 (0.2%), in-trial [CSR PDF p. 128]" }, { "id": "600321283", "alias": "Systematic review \u2014 harms \u2014 causes of death description", "group": "Systematic review", "state": "answered", "chars": 13, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Death details" }, { "id": "77268508", "alias": "Systematic review \u2014 harms \u2014 deaths detail \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 77, "cited_pages": [ 134 ], "sentence_checks": [], "numbers": { "198": "on_cited_page", "311": "on_cited_page" }, "bracket_cites": 1, "text": "EAC: sudden cardiac death, day 311; product stopped day 198. [CSR PDF p. 134]" }, { "id": "1083791034", "alias": "Systematic review \u2014 harms \u2014 deaths detail \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 120, "cited_pages": [ 134 ], "sentence_checks": [], "numbers": { "145": "on_cited_page" }, "bracket_cites": 1, "text": "EAC: malignancy, day 145; fatal events included aspiration pneumonia and sepsis. Some details redacted. [CSR PDF p. 134]" }, { "id": "1522498328", "alias": "Systematic review \u2014 harms \u2014 special-interest event name", "group": "Systematic review", "state": "answered", "chars": 53, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Gallbladder disorders; adjudicated acute pancreatitis" }, { "id": "1533928334", "alias": "Systematic review \u2014 harms \u2014 special-interest event \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 51, "cited_pages": [ 129 ], "sentence_checks": [], "numbers": { "0.2%": "on_cited_page", "2.6%": "on_cited_page" }, "bracket_cites": 1, "text": "34 (2.6%); 3 (0.2%), respectively. [CSR PDF p. 129]" }, { "id": "1291278805", "alias": "Systematic review \u2014 harms \u2014 special-interest event \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 43, "cited_pages": [ 129 ], "sentence_checks": [], "numbers": { "1.2%": "on_cited_page" }, "bracket_cites": 1, "text": "8 (1.2%); 0, respectively. [CSR PDF p. 129]" }, { "id": "25554223", "alias": "Safety evaluation plan", "group": "Safety evaluation plan", "state": "answered", "chars": 495, "cited_pages": [ 49, 50, 51, 52, 53, 54 ], "sentence_checks": [], "numbers": { "655": "elsewhere", "1306": "elsewhere", "22.1": "on_cited_page", "1961": "elsewhere" }, "bracket_cites": 1, "text": "SAS analysed as treated: all 1961 randomised/exposed participants (1306/655). AE summaries use onset within the on-treatment window, including 49 days after dosing. Deaths, cardiovascular events and neoplasms use in-trial follow-up. Selected events underwent independent EAC adjudication; MedDRA 22.1 coding was used. Clinical/laboratory safety assessments used the specified observation periods. This is STEP 1 safety, not a pooled development-programme analysis. [CSR PDF pp. 49-54,58,128-129]" }, { "id": "1037532054", "alias": "Systematic review \u2014 safety evaluation plan", "group": "Systematic review", "state": "answered", "chars": 495, "cited_pages": [ 49, 50, 51, 52, 53, 54 ], "sentence_checks": [], "numbers": { "655": "elsewhere", "1306": "elsewhere", "22.1": "on_cited_page", "1961": "elsewhere" }, "bracket_cites": 1, "text": "SAS analysed as treated: all 1961 randomised/exposed participants (1306/655). AE summaries use onset within the on-treatment window, including 49 days after dosing. Deaths, cardiovascular events and neoplasms use in-trial follow-up. Selected events underwent independent EAC adjudication; MedDRA 22.1 coding was used. Clinical/laboratory safety assessments used the specified observation periods. This is STEP 1 safety, not a pooled development-programme analysis. [CSR PDF pp. 49-54,58,128-129]" }, { "id": "298910876", "alias": "Systematic review \u2014 overview of safety", "group": "Systematic review", "state": "answered", "chars": 360, "cited_pages": [ 128, 131 ], "sentence_checks": [ { "cited": 128, "best": 174, "score": 2, "delta": 46 } ], "numbers": { "1171": "on_cited_page", "5%": "on_cited_page", "566": "on_cited_page", "1306": "on_cited_page", "128": "on_cited_page", "0.1%": "on_cited_page", "655": "on_cited_page", "3.1%": "on_cited_page", "89.7%": "on_cited_page", "86.4%": "on_cited_page", "9.8%": "on_cited_page", "0.2%": "on_cited_page", "7.0%": "on_cited_page", "6.4%": "on_cited_page" }, "bracket_cites": 2, "text": "STEP 1 SAS: 1306 semaglutide and 655 placebo. TEAEs occurred in 1171 (89.7%) versus 566 (86.4%); SAEs in 128 (9.8%) versus 42 (6.4%); AEs leading to permanent treatment discontinuation in 92 (7.0%) versus 20 (3.1%). In-trial deaths: 1 (0.1%) versus 1 (0.2%). [CSR PDF p. 128; Table 12-1] Common-event threshold in the CSR is \u22655% in either arm. [CSR PDF p. 131]" }, { "id": "1812042767", "alias": "Overview of safety", "group": "Overview of safety", "state": "answered", "chars": 360, "cited_pages": [ 128, 131 ], "sentence_checks": [ { "cited": 128, "best": 174, "score": 2, "delta": 46 } ], "numbers": { "1171": "on_cited_page", "5%": "on_cited_page", "566": "on_cited_page", "1306": "on_cited_page", "128": "on_cited_page", "0.1%": "on_cited_page", "655": "on_cited_page", "3.1%": "on_cited_page", "89.7%": "on_cited_page", "86.4%": "on_cited_page", "9.8%": "on_cited_page", "0.2%": "on_cited_page", "7.0%": "on_cited_page", "6.4%": "on_cited_page" }, "bracket_cites": 2, "text": "STEP 1 SAS: 1306 semaglutide and 655 placebo. TEAEs occurred in 1171 (89.7%) versus 566 (86.4%); SAEs in 128 (9.8%) versus 42 (6.4%); AEs leading to permanent treatment discontinuation in 92 (7.0%) versus 20 (3.1%). In-trial deaths: 1 (0.1%) versus 1 (0.2%). [CSR PDF p. 128; Table 12-1] Common-event threshold in the CSR is \u22655% in either arm. [CSR PDF p. 131]" }, { "id": "8283627", "alias": "Treatment-emergent adverse events", "group": "Treatment-emergent adverse events", "state": "answered", "chars": 732, "cited_pages": [ 128, 141 ], "sentence_checks": [ { "cited": 128, "best": 174, "score": 2, "delta": 46 }, { "cited": 141, "best": 141, "score": 7, "delta": 0 } ], "numbers": { "104": "on_cited_page", "3.1%": "on_cited_page", "17.4": "on_cited_page", "5.0": "on_cited_page", "7.4": "on_cited_page", "3.2": "on_cited_page", "6.6": "on_cited_page", "1306": "on_cited_page", "0.2%": "on_cited_page", "7.0%": "on_cited_page", "6.4%": "on_cited_page", "8.6": "on_cited_page", "412": "on_cited_page", "324": "on_cited_page", "89.7%": "on_cited_page", "3.5": "on_cited_page", "9.8%": "on_cited_page", "10.3": "on_cited_page", "15.9": "on_cited_page", "112": "on_cited_page", "306": "on_cited_page", "1171": "on_cited_page", "9.6": "on_cited_page", "577": "on_cited_page", "566": "on_cited_page", "9.5": "on_cited_page", "3.1": "on_cited_page", "6.3": "on_cited_page", "10.0": "on_cited_page", "23.4": "on_cited_page", "0.5": "on_cited_page", "24.8": "on_cited_page", "655": "on_cited_page", "114": "on_cited_page", "5.3": "on_cited_page", "125": "on_cited_page", "128": "on_cited_page", "44.2": "on_cited_page", "0.1%": "on_cited_page", "5.5": "on_cited_page", "31.5": "on_cited_page", "86.4%": "on_cited_page", "130": "on_cited_page", "4.7": "on_cited_page", "135": "on_cited_page" }, "bracket_cites": 2, "text": "STEP 1 SAS: 1306 semaglutide and 655 placebo. TEAEs occurred in 1171 (89.7%) versus 566 (86.4%); SAEs in 128 (9.8%) versus 42 (6.4%); AEs leading to permanent treatment discontinuation in 92 (7.0%) versus 20 (3.1%). In-trial deaths: 1 (0.1%) versus 1 (0.2%). [CSR PDF p. 128; Table 12-1] Common GI preferred terms, semaglutide/placebo n (%): nausea 577 (44.2)/114 (17.4); diarrhoea 412 (31.5)/104 (15.9); vomiting 324 (24.8)/43 (6.6); constipation 306 (23.4)/62 (9.5); dyspepsia 135 (10.3)/23 (3.5); abdominal pain 130 (10.0)/36 (5.5); upper abdominal pain 125 (9.6)/35 (5.3); eructation 112 (8.6)/3 " }, { "id": "680440901", "alias": "Systematic review \u2014 adverse events narrative", "group": "Systematic review", "state": "answered", "chars": 732, "cited_pages": [ 128, 141 ], "sentence_checks": [ { "cited": 128, "best": 174, "score": 2, "delta": 46 }, { "cited": 141, "best": 141, "score": 7, "delta": 0 } ], "numbers": { "104": "on_cited_page", "3.1%": "on_cited_page", "17.4": "on_cited_page", "5.0": "on_cited_page", "7.4": "on_cited_page", "3.2": "on_cited_page", "6.6": "on_cited_page", "1306": "on_cited_page", "0.2%": "on_cited_page", "7.0%": "on_cited_page", "6.4%": "on_cited_page", "8.6": "on_cited_page", "412": "on_cited_page", "324": "on_cited_page", "89.7%": "on_cited_page", "3.5": "on_cited_page", "9.8%": "on_cited_page", "10.3": "on_cited_page", "15.9": "on_cited_page", "112": "on_cited_page", "306": "on_cited_page", "1171": "on_cited_page", "9.6": "on_cited_page", "577": "on_cited_page", "566": "on_cited_page", "9.5": "on_cited_page", "3.1": "on_cited_page", "6.3": "on_cited_page", "10.0": "on_cited_page", "23.4": "on_cited_page", "0.5": "on_cited_page", "24.8": "on_cited_page", "655": "on_cited_page", "114": "on_cited_page", "5.3": "on_cited_page", "125": "on_cited_page", "128": "on_cited_page", "44.2": "on_cited_page", "0.1%": "on_cited_page", "5.5": "on_cited_page", "31.5": "on_cited_page", "86.4%": "on_cited_page", "130": "on_cited_page", "4.7": "on_cited_page", "135": "on_cited_page" }, "bracket_cites": 2, "text": "STEP 1 SAS: 1306 semaglutide and 655 placebo. TEAEs occurred in 1171 (89.7%) versus 566 (86.4%); SAEs in 128 (9.8%) versus 42 (6.4%); AEs leading to permanent treatment discontinuation in 92 (7.0%) versus 20 (3.1%). In-trial deaths: 1 (0.1%) versus 1 (0.2%). [CSR PDF p. 128; Table 12-1] Common GI preferred terms, semaglutide/placebo n (%): nausea 577 (44.2)/114 (17.4); diarrhoea 412 (31.5)/104 (15.9); vomiting 324 (24.8)/43 (6.6); constipation 306 (23.4)/62 (9.5); dyspepsia 135 (10.3)/23 (3.5); abdominal pain 130 (10.0)/36 (5.5); upper abdominal pain 125 (9.6)/35 (5.3); eructation 112 (8.6)/3 " }, { "id": "1300731115", "alias": "Serious adverse events", "group": "Serious adverse events", "state": "answered", "chars": 203, "cited_pages": [ 128 ], "sentence_checks": [], "numbers": { "1.3%": "elsewhere", "164": "on_cited_page", "1306": "on_cited_page", "128": "on_cited_page", "655": "on_cited_page", "9.8%": "on_cited_page", "0.2%": "on_cited_page", "1.4%": "elsewhere", "6.4%": "on_cited_page" }, "bracket_cites": 1, "text": "On-treatment SAEs: 128/1306 (9.8%; 164 events) versus 42/655 (6.4%; 53 events). Serious GI disorders: 18 (1.4%) versus 0; serious hepatobiliary disorders: 17 (1.3%) versus 1 (0.2%). [CSR PDF pp. 128,135]" }, { "id": "1418799728", "alias": "Systematic review \u2014 serious adverse events narrative", "group": "Systematic review", "state": "answered", "chars": 203, "cited_pages": [ 128 ], "sentence_checks": [], "numbers": { "1.3%": "elsewhere", "164": "on_cited_page", "1306": "on_cited_page", "128": "on_cited_page", "655": "on_cited_page", "9.8%": "on_cited_page", "0.2%": "on_cited_page", "1.4%": "elsewhere", "6.4%": "on_cited_page" }, "bracket_cites": 1, "text": "On-treatment SAEs: 128/1306 (9.8%; 164 events) versus 42/655 (6.4%; 53 events). Serious GI disorders: 18 (1.4%) versus 0; serious hepatobiliary disorders: 17 (1.3%) versus 1 (0.2%). [CSR PDF pp. 128,135]" }, { "id": "1407394812", "alias": "Withdrawls", "group": "Withdrawls", "state": "answered", "chars": 788, "cited_pages": [ 136, 137, 138 ], "sentence_checks": [ { "cited": 136, "best": 136, "score": 2, "delta": 0 } ], "numbers": { "126": "on_cited_page", "124": "on_cited_page", "3.2%": "on_cited_page", "9.5%": "on_cited_page", "4.5%": "on_cited_page", "0.8%": "on_cited_page", "0.6%": "on_cited_page", "3.1%": "on_cited_page", "4.0%": "on_cited_page", "9.6%": "on_cited_page", "7.0%": "on_cited_page" }, "bracket_cites": 2, "text": "AE-form permanent product discontinuations were 92 (7.0%) versus 20 (3.1%), including GI disorders 59 (4.5%) versus 5 (0.8%). Disposition-form AE discontinuations were 91 (7.0%) versus 21 (3.2%); the CSR explicitly attributes the one-person-per-arm discrepancy to different forms. Temporary interruptions due to AEs: 126 (9.6%) versus 26 (4.0%); dose reductions: 124 (9.5%) versus 4 (0.6%). These are product changes, distinct from complete trial withdrawal. [CSR PDF pp. 137-138; Table 12-8] AE-related trial-withdrawal information was not systematically collected; Table 12-7 lists 4 semaglutide an" }, { "id": "517772690", "alias": "Withdrawals due to adverse events", "group": "Withdrawals due to adverse events", "state": "answered", "chars": 788, "cited_pages": [ 136, 137, 138 ], "sentence_checks": [ { "cited": 136, "best": 136, "score": 2, "delta": 0 } ], "numbers": { "126": "on_cited_page", "124": "on_cited_page", "3.2%": "on_cited_page", "9.5%": "on_cited_page", "4.5%": "on_cited_page", "0.8%": "on_cited_page", "0.6%": "on_cited_page", "3.1%": "on_cited_page", "4.0%": "on_cited_page", "9.6%": "on_cited_page", "7.0%": "on_cited_page" }, "bracket_cites": 2, "text": "AE-form permanent product discontinuations were 92 (7.0%) versus 20 (3.1%), including GI disorders 59 (4.5%) versus 5 (0.8%). Disposition-form AE discontinuations were 91 (7.0%) versus 21 (3.2%); the CSR explicitly attributes the one-person-per-arm discrepancy to different forms. Temporary interruptions due to AEs: 126 (9.6%) versus 26 (4.0%); dose reductions: 124 (9.5%) versus 4 (0.6%). These are product changes, distinct from complete trial withdrawal. [CSR PDF pp. 137-138; Table 12-8] AE-related trial-withdrawal information was not systematically collected; Table 12-7 lists 4 semaglutide an" }, { "id": "1880334514", "alias": "Adverse events of special interest", "group": "Adverse events of special interest", "state": "answered", "chars": 643, "cited_pages": [ 38, 39, 40, 129 ], "sentence_checks": [ { "cited": 129, "best": 129, "score": 4, "delta": 0 } ], "numbers": { "0.8": "on_cited_page", "0.2": "on_cited_page", "5.0": "on_cited_page", "1.1": "on_cited_page", "7.4": "on_cited_page", "8.2": "on_cited_page", "12.7": "on_cited_page", "11.5": "on_cited_page", "6.7": "on_cited_page", "124": "on_cited_page", "2.6": "on_cited_page", "1.2": "on_cited_page", "969": "on_cited_page", "3.1": "on_cited_page", "9.5": "on_cited_page", "74.2": "on_cited_page", "107": "on_cited_page", "47.9": "on_cited_page", "2.4": "on_cited_page", "0.6": "on_cited_page", "314": "on_cited_page", "0.3": "on_cited_page" }, "bracket_cites": 2, "text": "Safety focus areas, semaglutide/placebo n (%): GI 969 (74.2)/314 (47.9); gallbladder 34 (2.6)/8 (1.2); adjudicated acute pancreatitis 3 (0.2)/0; cardiovascular (in-trial) 107 (8.2)/75 (11.5); malignant neoplasms (in-trial) 14 (1.1)/7 (1.1); hepatic 31 (2.4)/20 (3.1); acute renal failure 3 (0.2)/2 (0.3); hypoglycaemia 8 (0.6)/5 (0.8); injection-site reactions 65 (5.0)/44 (6.7); allergy 96 (7.4)/54 (8.2); psychiatric 124 (9.5)/83 (12.7). 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[CSR PDF p. 129; Table 12-2] Dose escalation/lower maintenance dose supported GI tolerability; suspected pancreatitis required stopping product with protocol-de" }, { "id": "1546147757", "alias": "Systematic review \u2014 sponsor summary and conclusion", "group": "Systematic review", "state": "answered", "chars": 154, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "The CSR confirms superiority for all eight confirmatory efficacy endpoints, with more gastrointestinal adverse events on semaglutide. [CSR PDF pp. 87,129]" }, { "id": "886376493", "alias": "Summary and conclusions", "group": "Summary and conclusions", "state": "answered", "chars": 1048, "cited_pages": [ 87, 128, 129, 333 ], "sentence_checks": [ { "cited": 128, "best": 174, "score": 2, "delta": 46 }, { "cited": 129, "best": 190, "score": 3, "delta": 61 } ], "numbers": { "68,": "on_cited_page", "-5.10": "on_cited_page", "1.18": "on_cited_page", "11.08": "on_cited_page", "3.1%": "on_cited_page", "-12.44": "on_cited_page", "15%": "on_cited_page", "0.2%": "on_cited_page", "1306": "on_cited_page", "7.0%": "on_cited_page", "-14.85%": "on_cited_page", "6.4%": "on_cited_page", "9.43": "on_cited_page", "-8.53": "on_cited_page", "-6.34": "on_cited_page", "89.7%": "on_cited_page", "1212": "on_cited_page", "12.89": "on_cited_page", "9.8%": "on_cited_page", "-2.41%": "on_cited_page", "2.42": "on_cited_page", "1.80": "on_cited_page", "1171": "on_cited_page", "11.35": "on_cited_page", "577": "on_cited_page", "566": "on_cited_page", "95%": "on_cited_page", "19.26": "on_cited_page", "-11.51": "on_cited_page", "0.0001": "elsewhere", "655": "on_cited_page", "-13.37": "on_cited_page", "-3.87": "on_cited_page", "28.76": "on_cited_page", "7.50": "on_cited_page", "14.68": "on_cited_page", "128": "on_cited_page", "-10.30": "on_cited_page", "0.1%": "on_cited_page", "86.4%": "on_cited_page", "10%": "on_cited_page", "-9.42": "on_cited_page", "19.44": "on_cited_page" }, "bracket_cites": 4, "text": "At week 68, treatment-policy estimated weight change was -14.85% with semaglutide and -2.41% with placebo: difference -12.44 percentage points (95% CI -13.37 to -11.51), p<0.0001. FAS n=1306/655; observed week-68 weight n=1212/577. [CSR PDF p. 333; Table 14.2.9] Confirmatory week-68 treatment-policy differences: waist -9.42 cm (95% CI -10.30 to -8.53), systolic BP -5.10 mmHg (-6.34 to -3.87), SF-36 physical functioning +1.80 (1.18-2.42), IWQOL physical function +9.43 (7.50-11.35); all p<0.0001. \u226510% and \u226515% weight-loss ORs were 14.68 (11.08-19.44) and 19.26 (12.89-28.76). [CSR PDF p. 87" }, { "id": "957324082", "alias": "Systematic review \u2014 sponsor identified gaps", "group": "Systematic review", "state": "answered", "chars": 104, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Evidence gaps concern active comparators, excluded populations and longer follow-up. [CSR PDF pp. 35-37]" }, { "id": "1748456287", "alias": "Gaps in the evidence", "group": "Gaps in the evidence", "state": "answered", "chars": 409, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "CSR scope limits: no active-drug comparison; adults without diabetes; main treatment duration 68 weeks plus safety follow-up to week 75; extension results excluded. Thus comparative efficacy against other drugs, effects in excluded populations and longer-term durability cannot be established from this CSR. [CSR PDF pp. 35-37] No sponsor-authored gap assessment or separate gap-addressing report is supplied." }, { "id": "1100246410", "alias": "Long-term - Description of studies: Study design and objectives", "group": "Long-term", "state": "answered", "chars": 223, "cited_pages": [ 32 ], "sentence_checks": [], "numbers": { "300": "elsewhere" }, "bracket_cites": 1, "text": "Planned 52-week open-label off-treatment extension of STEP 1; approximately 300 selected main-phase completers from Canada, Germany, Japan, UK and US. Extension results were to be reported separately. [CSR PDF pp. 32,35-36]" }, { "id": "1563606667", "alias": "Long-term - Description of studies: Eligibility criteria", "group": "Long-term", "state": "not_in_csr", "chars": 206, "text": "Subset completing main phase on maintenance-dose semaglutide 2.4 mg or matching placebo, at selected sites/countries. [CSR PDF p. 35] Full extension eligibility details are not reported in the supplied CSR.", "csr_pages_with_field_terms": 9 }, { "id": "1790111029", "alias": "Long-term - Description of studies: Intervention", "group": "Long-term", "state": "answered", "chars": 114, "cited_pages": [ 35 ], "sentence_checks": [ { "cited": 35, "best": 35, "score": 2, "delta": 0 } ], "numbers": {}, "bracket_cites": 1, "text": "No study drug and no structured lifestyle intervention during the 52-week off-treatment extension. [CSR PDF p. 35]" }, { "id": "491286797", "alias": "Long-term - Description of studies: Outcomes", "group": "Long-term", "state": "answered", "chars": 139, "cited_pages": [ 35, 36 ], "sentence_checks": [ { "cited": 35, "best": 36, "score": 5, "delta": 1 } ], "numbers": {}, "bracket_cites": 1, "text": "Planned evaluation of change after end of treatment in body weight, cardiovascular risk factors and glucose metabolism. [CSR PDF pp. 35-36]" }, { "id": "219415411", "alias": "Long-term - Description of studies: Statistical analysis", "group": "Long-term", "state": "not_in_csr", "chars": 193, "text": "Extension statistical methods and baseline definitions are not reported in this CSR. Not reported: extension results are outside this CSR and were to be reported separately. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 18 }, { "id": "1415065320", "alias": "Patient population: Baseline characteristics", "group": "Patient population: Baseline characteristics", "state": "not_in_csr", "chars": 108, "text": "Not reported: extension results are outside this CSR and were to be reported separately. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 26 }, { "id": "860771384", "alias": "Long-term extension \u2014 baseline characteristics \u2014 Study 1 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 82 }, { "id": "1018778104", "alias": "Long-term extension \u2014 baseline characteristics \u2014 Study 1 treatment 1 sample size", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 83 }, { "id": "1406005034", "alias": "Long-term extension \u2014 baseline characteristics \u2014 Study 1 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 82 }, { "id": "65192411", "alias": "Long-term extension \u2014 baseline characteristics \u2014 Study 1 treatment 2 sample size", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. 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[CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 83 }, { "id": "968548643", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 2 name", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 12 }, { "id": "1132590584", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 2 \u2014 Study 1 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 83 }, { "id": "1575666822", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 2 \u2014 Study 1 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 83 }, { "id": "1075297296", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 2 \u2014 Study 2 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 83 }, { "id": "592307323", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 2 \u2014 Study 2 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 83 }, { "id": "1630721083", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 3 name", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 12 }, { "id": "489454230", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 3 \u2014 Study 1 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 83 }, { "id": "891586790", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 3 \u2014 Study 1 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 83 }, { "id": "831097390", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 3 \u2014 Study 2 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. 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[CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 0 }, { "id": "1104228471", "alias": "Long-term extension \u2014 patient exposure \u2014 Study 1 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 31 }, { "id": "316662216", "alias": "Long-term extension \u2014 patient exposure \u2014 Study 1 treatment 1 sample size", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 35 }, { "id": "1793804968", "alias": "Long-term extension \u2014 patient exposure \u2014 Study 1 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 31 }, { "id": "1112836441", "alias": "Long-term extension \u2014 patient exposure \u2014 Study 1 treatment 2 sample size", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 35 }, { "id": "2046945725", "alias": "Long-term extension \u2014 patient exposure \u2014 Study 2 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 31 }, { "id": "228398045", "alias": "Long-term extension \u2014 patient exposure \u2014 Study 2 treatment 1 sample size", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 35 }, { "id": "1218071684", "alias": "Long-term extension \u2014 patient exposure \u2014 Study 2 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 31 }, { "id": "923021044", "alias": "Long-term extension \u2014 patient exposure \u2014 Study 2 treatment 2 sample size", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 35 }, { "id": "687473353", "alias": "Long-term extension \u2014 patient exposure \u2014 total exposure \u2014 Study 1 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 70 }, { "id": "15627698", "alias": "Long-term extension \u2014 patient exposure \u2014 total exposure \u2014 Study 1 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 70 }, { "id": "1395608667", "alias": "Long-term extension \u2014 patient exposure \u2014 total exposure \u2014 Study 2 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 70 }, { "id": "1397983571", "alias": "Long-term extension \u2014 patient exposure \u2014 total exposure \u2014 Study 2 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 70 }, { "id": "972909407", "alias": "Long-term extension \u2014 patient exposure \u2014 mean duration \u2014 Study 1 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 84 }, { "id": "1668824096", "alias": "Long-term extension \u2014 patient exposure \u2014 mean duration \u2014 Study 1 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 84 }, { "id": "489955367", "alias": "Long-term extension \u2014 patient exposure \u2014 mean duration \u2014 Study 2 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 84 }, { "id": "293077732", "alias": "Long-term extension \u2014 patient exposure \u2014 mean duration \u2014 Study 2 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 84 }, { "id": "1693803272", "alias": "Long-term extension \u2014 patient exposure \u2014 median duration \u2014 Study 1 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 44 }, { "id": "799762949", "alias": "Long-term extension \u2014 patient exposure \u2014 median duration \u2014 Study 1 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 44 }, { "id": "1715456774", "alias": "Long-term extension \u2014 patient exposure \u2014 median duration \u2014 Study 2 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 44 }, { "id": "1510024955", "alias": "Long-term extension \u2014 patient exposure \u2014 median duration \u2014 Study 2 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 44 }, { "id": "992377972", "alias": "Long-term extension \u2014 patient exposure \u2014 adherence \u2014 Study 1 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 32 }, { "id": "195201594", "alias": "Long-term extension \u2014 patient exposure \u2014 adherence \u2014 Study 1 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 32 }, { "id": "1504423395", "alias": "Long-term extension \u2014 patient exposure \u2014 adherence \u2014 Study 2 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 32 }, { "id": "1382578428", "alias": "Long-term extension \u2014 patient exposure \u2014 adherence \u2014 Study 2 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 32 }, { "id": "682740380", "alias": "Long-term: Concomitant medications and co-interventions", "group": "Long-term: Concomitant medications and co-interventions", "state": "not_in_csr", "chars": 133, "text": "No structured lifestyle intervention during the extension. [CSR PDF p. 35] Extension concomitant-medication results are not reported.", "csr_pages_with_field_terms": 1 }, { "id": "1673917880", "alias": "Subsequent treatment", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 164, "text": "Off-treatment follow-up after the main phase; no extension switch to active therapy is described. [CSR PDF pp. 35-36] Subsequent-treatment results are not reported.", "csr_pages_with_field_terms": 0 }, { "id": "2069259673", "alias": "Subsequent treatment table \u2014 number", "group": "Subsequent treatment table", "state": "answered", "chars": 2, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "11" }, { "id": "1253870556", "alias": "Long-term extension \u2014 subsequent treatment \u2014 Study 1 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 130 }, { "id": "125308987", "alias": "Long-term extension \u2014 subsequent treatment \u2014 Study 1 treatment 1 sample size", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. 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[CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 130 }, { "id": "2122123324", "alias": "Long-term extension \u2014 subsequent treatment \u2014 therapy 2 \u2014 Study 2 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 130 }, { "id": "183102924", "alias": "Long-term extension \u2014 subsequent treatment \u2014 therapy 2 \u2014 Study 2 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 130 }, { "id": "2066680307", "alias": "Long-term extension \u2014 efficacy outcomes overview", "group": "Long-term extension", "state": "not_in_csr", "chars": 108, "text": "Not reported: extension results are outside this CSR and were to be reported separately. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 5 }, { "id": "1901184427", "alias": "Long-term extension \u2014 efficacy endpoint 1 heading", "group": "Long-term extension", "state": "not_in_csr", "chars": 44, "text": "Body weight (extension results not reported)", "csr_pages_with_field_terms": 6 }, { "id": "1736256802", "alias": "Long-term extension \u2014 efficacy endpoint 2 heading", "group": "Long-term extension", "state": "not_in_csr", "chars": 60, "text": "Cardiovascular risk factors (extension results not reported)", "csr_pages_with_field_terms": 6 }, { "id": "448560176", "alias": "Long-term extension \u2014 efficacy endpoint 3 heading", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Glucose metabolism (extension results not reported)", "csr_pages_with_field_terms": 6 }, { "id": "400911679", "alias": "Long-term : Harms", "group": "Long-term : Harms", "state": "not_in_csr", "chars": 108, "text": "Not reported: extension results are outside this CSR and were to be reported separately. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 0 }, { "id": "2127029719", "alias": "Long-term extension \u2014 harms table number", "group": "Long-term extension", "state": "answered", "chars": 2, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "12" }, { "id": "1689685049", "alias": "Long-term extension \u2014 harms \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 4 }, { "id": "704163184", "alias": "Long-term extension \u2014 harms \u2014 treatment 1 sample size", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. 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[CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 63 }, { "id": "1161473698", "alias": "Long-term extension \u2014 harms \u2014 \u2265 1 adverse event \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 63 }, { "id": "583271820", "alias": "Long-term extension \u2014 harms \u2014 adverse event 1 name", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 41 }, { "id": "85530822", "alias": "Long-term extension \u2014 harms \u2014 adverse event 1 \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 63 }, { "id": "1004057761", "alias": "Long-term extension \u2014 harms \u2014 adverse event 1 \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 63 }, { "id": "191311252", "alias": "Long-term extension \u2014 harms \u2014 adverse event 2 name", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 41 }, { "id": "1723887216", "alias": "Long-term extension \u2014 harms \u2014 adverse event 2 \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 63 }, { "id": "1923920028", "alias": "Long-term extension \u2014 harms \u2014 adverse event 2 \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 63 }, { "id": "776854055", "alias": "Long-term extension \u2014 harms \u2014 patients with \u2265 1 SAE \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 7 }, { "id": "303723184", "alias": "Long-term extension \u2014 harms \u2014 patients with \u2265 1 SAE \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 7 }, { "id": "1288993385", "alias": "Long-term extension \u2014 harms \u2014 SAE 1 name", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 2 }, { "id": "1884585250", "alias": "Long-term extension \u2014 harms \u2014 SAE 1 \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 4 }, { "id": "323727383", "alias": "Long-term extension \u2014 harms \u2014 SAE 1 \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 4 }, { "id": "959558203", "alias": "Long-term extension \u2014 harms \u2014 SAE 2 name", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 2 }, { "id": "289648320", "alias": "Long-term extension \u2014 harms \u2014 SAE 2 \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 4 }, { "id": "687739638", "alias": "Long-term extension \u2014 harms \u2014 SAE 2 \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 4 }, { "id": "451052731", "alias": "Long-term extension \u2014 harms \u2014 patients who stopped treatment \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 130 }, { "id": "95369199", "alias": "Long-term extension \u2014 harms \u2014 patients who stopped treatment \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 130 }, { "id": "461389432", "alias": "Long-term extension \u2014 harms \u2014 stopped-treatment adverse event 1 name", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 41 }, { "id": "508443590", "alias": "Long-term extension \u2014 harms \u2014 stopped-treatment adverse event 1 \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 63 }, { "id": "1504985604", "alias": "Long-term extension \u2014 harms \u2014 stopped-treatment adverse event 1 \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 63 }, { "id": "1190689201", "alias": "Long-term extension \u2014 harms \u2014 stopped-treatment adverse event 2 name", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 41 }, { "id": "563934557", "alias": "Long-term extension \u2014 harms \u2014 stopped-treatment adverse event 2 \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 63 }, { "id": "889519286", "alias": "Long-term extension \u2014 harms \u2014 stopped-treatment adverse event 2 \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 63 }, { "id": "1908809376", "alias": "Long-term extension \u2014 harms \u2014 patients who died \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 11 }, { "id": "1270362143", "alias": "Long-term extension \u2014 harms \u2014 patients who died \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 11 }, { "id": "1953910705", "alias": "Long-term extension \u2014 harms \u2014 causes of death description", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 2 }, { "id": "557704723", "alias": "Long-term extension \u2014 harms \u2014 deaths detail \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 7 }, { "id": "19432884", "alias": "Long-term extension \u2014 harms \u2014 deaths detail \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 7 }, { "id": "1384584813", "alias": "Long-term extension \u2014 harms \u2014 special-interest event name", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 2 }, { "id": "1577482172", "alias": "Long-term extension \u2014 harms \u2014 special-interest event \u2014 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 37 }, { "id": "1862679142", "alias": "Long-term extension \u2014 harms \u2014 special-interest event \u2014 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 51, "text": "Extension results not reported. [CSR PDF pp. 35-36]", "csr_pages_with_field_terms": 37 }, { "id": "425283575", "alias": "Long-term extension \u2014 sponsor summary and conclusion", "group": "Long-term extension", "state": "not_in_csr", "chars": 332, "text": "Planned 52-week open-label off-treatment extension of STEP 1; approximately 300 selected main-phase completers from Canada, Germany, Japan, UK and US. Extension results were to be reported separately. [CSR PDF pp. 32,35-36] Not reported: extension results are outside this CSR and were to be reported", "csr_pages_with_field_terms": 0 }, { "id": "2084997880", "alias": "Sponsor summary and conclusion", "group": "Sponsor summary and conclusion", "state": "not_in_csr", "chars": 332, "text": "Planned 52-week open-label off-treatment extension of STEP 1; approximately 300 selected main-phase completers from Canada, Germany, Japan, UK and US. Extension results were to be reported separately. [CSR PDF pp. 32,35-36] Not reported: extension results are outside this CSR and were to be reported", "csr_pages_with_field_terms": null }, { "id": "167119208", "alias": "Long-term extension \u2014 sponsor identified gaps", "group": "Long-term extension", "state": "answered", "chars": 142, "cited_pages": [ 35, 36 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Durability after withdrawal and longer-term outcomes cannot be assessed because extension results are outside this report. [CSR PDF pp. 35-36]" }, { "id": "1502989581", "alias": "Gaps", "group": "Gaps", "state": "answered", "chars": 142, "cited_pages": [ 35, 36 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "Durability after withdrawal and longer-term outcomes cannot be assessed because extension results are outside this report. [CSR PDF pp. 35-36]" }, { "id": "764049985", "alias": "ITC - Objectives", "group": "ITC", "state": "not_in_csr", "chars": 119, "text": "Not reported in this CSR; it reports a direct placebo-controlled trial, not an indirect comparison. [CSR PDF pp. 35-37]", "csr_pages_with_field_terms": null }, { "id": "656653656", "alias": "Study selection methods", "group": "Study selection methods", "state": "not_in_csr", "chars": 119, "text": "Not reported in this CSR; it reports a direct placebo-controlled trial, not an indirect comparison. [CSR PDF pp. 35-37]", "csr_pages_with_field_terms": 0 }, { "id": "1220217955", "alias": "Indirect comparison \u2014 selection criteria \u2014 population", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1931836581", "alias": "Indirect comparison \u2014 selection criteria \u2014 intervention", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1527988822", "alias": "Indirect comparison \u2014 selection criteria \u2014 comparators", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "372248821", "alias": "Indirect comparison \u2014 selection criteria \u2014 outcomes", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1649929290", "alias": "Indirect comparison \u2014 selection criteria \u2014 study designs", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "2005341435", "alias": "Indirect comparison \u2014 selection criteria \u2014 publication characteristics", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1592170354", "alias": "Indirect comparison \u2014 selection criteria \u2014 exclusion criteria", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "865598486", "alias": "Indirect comparison \u2014 selection criteria \u2014 databases searched", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "988005254", "alias": "Indirect comparison \u2014 selection criteria \u2014 selection process", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "815613641", "alias": "Indirect comparison \u2014 selection criteria \u2014 data extraction process", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1404626440", "alias": "Indirect comparison \u2014 selection criteria \u2014 quality assessment", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1685979330", "alias": "Indirect comparison \u2014 analysis methods \u2014 analysis methods", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1603112739", "alias": "Indirect comparison \u2014 analysis methods \u2014 priors", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "201019478", "alias": "Indirect comparison \u2014 analysis methods \u2014 model fit assessment", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "517443726", "alias": "Indirect comparison \u2014 analysis methods \u2014 consistency assessment", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1820375432", "alias": "Indirect comparison \u2014 analysis methods \u2014 convergence assessment", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1610320730", "alias": "Indirect comparison \u2014 analysis methods \u2014 outcomes", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "935500728", "alias": "Indirect comparison \u2014 analysis methods \u2014 follow-up timepoints", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "461478005", "alias": "Indirect comparison \u2014 analysis methods \u2014 construction of nodes", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "230175398", "alias": "Indirect comparison \u2014 analysis methods \u2014 sensitivity analyses", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "562408401", "alias": "Indirect comparison \u2014 analysis methods \u2014 subgroup analysis", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1626573033", "alias": "Indirect comparison \u2014 analysis methods \u2014 pairwise meta-analysis methods", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "626519908", "alias": "Indirect comparison \u2014 homogeneity \u2014 disease severity", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "171266473", "alias": "Indirect comparison \u2014 homogeneity \u2014 treatment history", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "715193424", "alias": "Indirect comparison \u2014 homogeneity \u2014 trial eligibility criteria", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1198897289", "alias": "Indirect comparison \u2014 homogeneity \u2014 dosing of comparators", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1265773147", "alias": "Indirect comparison \u2014 homogeneity \u2014 placebo response", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1749147245", "alias": "Indirect comparison \u2014 homogeneity \u2014 endpoint definitions", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "296348191", "alias": "Indirect comparison \u2014 homogeneity \u2014 timing of endpoint evaluation", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1369000073", "alias": "Indirect comparison \u2014 homogeneity \u2014 withdrawal frequency", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "2019724292", "alias": "Indirect comparison \u2014 homogeneity \u2014 clinical trial setting", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "2027707133", "alias": "Indirect comparison \u2014 homogeneity \u2014 study design", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "159852965", "alias": "Indirect comparison \u2014 continuous outcomes \u2014 outcome 1 header", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "152209311", "alias": "Indirect comparison \u2014 continuous outcomes \u2014 outcome 2 header", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "239892466", "alias": "Indirect comparison \u2014 continuous outcomes \u2014 comparator 1 name", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "228677229", "alias": "Indirect comparison \u2014 continuous outcomes \u2014 comparator 1 \u2014 outcome 1", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "279834014", "alias": "Indirect comparison \u2014 continuous outcomes \u2014 comparator 1 \u2014 outcome 2", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "931854948", "alias": "Indirect comparison \u2014 continuous outcomes \u2014 comparator 2 name", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1983588840", "alias": "Indirect comparison \u2014 continuous outcomes \u2014 comparator 2 \u2014 outcome 1", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1403023323", "alias": "Indirect comparison \u2014 continuous outcomes \u2014 comparator 2 \u2014 outcome 2", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1025378523", "alias": "Indirect comparison \u2014 continuous outcomes \u2014 comparator 3 name", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1471190389", "alias": "Indirect comparison \u2014 continuous outcomes \u2014 comparator 3 \u2014 outcome 1", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1269535842", "alias": "Indirect comparison \u2014 continuous outcomes \u2014 comparator 3 \u2014 outcome 2", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "218753826", "alias": "Indirect comparison \u2014 dichotomous outcomes \u2014 outcome 1 header", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "904553015", "alias": "Indirect comparison \u2014 dichotomous outcomes \u2014 outcome 2 header", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "672981599", "alias": "Indirect comparison \u2014 dichotomous outcomes \u2014 comparator 1 name", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "885216680", "alias": "Indirect comparison \u2014 dichotomous outcomes \u2014 comparator 1 \u2014 outcome 1", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "771789635", "alias": "Indirect comparison \u2014 dichotomous outcomes \u2014 comparator 1 \u2014 outcome 2", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1656648519", "alias": "Indirect comparison \u2014 dichotomous outcomes \u2014 comparator 2 name", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "319886392", "alias": "Indirect comparison \u2014 dichotomous outcomes \u2014 comparator 2 \u2014 outcome 1", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "2072108177", "alias": "Indirect comparison \u2014 dichotomous outcomes \u2014 comparator 2 \u2014 outcome 2", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1275972865", "alias": "Indirect comparison \u2014 dichotomous outcomes \u2014 comparator 3 name", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1053497291", "alias": "Indirect comparison \u2014 dichotomous outcomes \u2014 comparator 3 \u2014 outcome 1", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1709767885", "alias": "Indirect comparison \u2014 dichotomous outcomes \u2014 comparator 3 \u2014 outcome 2", "group": "Indirect comparison", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No indirect comparison reported. [CSR PDF pp. 35-37]" }, { "id": "1538325956", "alias": "Other-design study \u2014 efficacy endpoint 1 heading", "group": "Other-design study", "state": "not_in_csr", "chars": 119, "text": "Not reported in this CSR; it reports a direct placebo-controlled trial, not an indirect comparison. [CSR PDF pp. 35-37]", "csr_pages_with_field_terms": 4 }, { "id": "76725622", "alias": "Other-design study \u2014 efficacy endpoint 2 heading", "group": "Other-design study", "state": "not_in_csr", "chars": 119, "text": "Not reported in this CSR; it reports a direct placebo-controlled trial, not an indirect comparison. [CSR PDF pp. 35-37]", "csr_pages_with_field_terms": 4 }, { "id": "1612865958", "alias": "Other-design study \u2014 efficacy endpoint 3 heading", "group": "Other-design study", "state": "not_in_csr", "chars": 119, "text": "Not reported in this CSR; it reports a direct placebo-controlled trial, not an indirect comparison. [CSR PDF pp. 35-37]", "csr_pages_with_field_terms": 4 }, { "id": "1981007380", "alias": "Indirect comparison \u2014 sponsor summary and conclusion", "group": "Indirect comparison", "state": "not_in_csr", "chars": 119, "text": "Not reported in this CSR; it reports a direct placebo-controlled trial, not an indirect comparison. [CSR PDF pp. 35-37]", "csr_pages_with_field_terms": 0 }, { "id": "1883415620", "alias": "Evidence gaps \u2014 gap description", "group": "Evidence gaps", "state": "answered", "chars": 409, "cited_pages": [ 35, 36, 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "CSR scope limits: no active-drug comparison; adults without diabetes; main treatment duration 68 weeks plus safety follow-up to week 75; extension results excluded. Thus comparative efficacy against other drugs, effects in excluded populations and longer-term durability cannot be established from this CSR. [CSR PDF pp. 35-37] No sponsor-authored gap assessment or separate gap-addressing report is supplied." }, { "id": "527459532", "alias": "Evidence gaps \u2014 addressing study description", "group": "Evidence gaps", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "344059515", "alias": "Evidence gaps \u2014 key results summary", "group": "Evidence gaps", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1803231675", "alias": "Other-design study \u2014 study ID (heading)", "group": "Other-design study", "state": "answered", "chars": 120, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional gap-addressing study is reported in this CSR; its scope is the STEP 1 main phase. [CSR PDF pp. 1,32,35-36]" }, { "id": "1427467093", "alias": "Other-design study \u2014 baseline characteristics \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "579985683", "alias": "Other-design study \u2014 baseline characteristics \u2014 Study 1 treatment 1 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1836536024", "alias": "Other-design study \u2014 baseline characteristics \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1704333009", "alias": "Other-design study \u2014 baseline characteristics \u2014 Study 1 treatment 2 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "91697836", "alias": "Other-design study \u2014 baseline characteristics \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1985125782", "alias": "Other-design study \u2014 baseline characteristics \u2014 Study 2 treatment 1 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1019899323", "alias": "Other-design study \u2014 baseline characteristics \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "356300774", "alias": "Other-design study \u2014 baseline characteristics \u2014 Study 2 treatment 2 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1895505513", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 1 name", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "514028036", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 1 \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1598447578", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 1 \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1276569996", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 1 \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "275205492", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 1 \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1245672051", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 2 name", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1077958665", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 2 \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "862451464", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 2 \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1917924410", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 2 \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "2159407", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 2 \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1405499924", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 3 name", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "597361886", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 3 \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1010336166", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 3 \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "2063565916", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 3 \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1031379371", "alias": "Other-design study \u2014 baseline characteristics \u2014 characteristic 3 \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1834766682", "alias": "Other-design study \u2014 patient exposure \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "54678570", "alias": "Other-design study \u2014 patient exposure \u2014 Study 1 treatment 1 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "194116649", "alias": "Other-design study \u2014 patient exposure \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "601062290", "alias": "Other-design study \u2014 patient exposure \u2014 Study 1 treatment 2 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1227791623", "alias": "Other-design study \u2014 patient exposure \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "46763209", "alias": "Other-design study \u2014 patient exposure \u2014 Study 2 treatment 1 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1481873822", "alias": "Other-design study \u2014 patient exposure \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "23703140", "alias": "Other-design study \u2014 patient exposure \u2014 Study 2 treatment 2 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "675561605", "alias": "Other-design study \u2014 patient exposure \u2014 total exposure \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "854506818", "alias": "Other-design study \u2014 patient exposure \u2014 total exposure \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1573025193", "alias": "Other-design study \u2014 patient exposure \u2014 total exposure \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "763146376", "alias": "Other-design study \u2014 patient exposure \u2014 total exposure \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "2090488996", "alias": "Other-design study \u2014 patient exposure \u2014 mean duration \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "243930847", "alias": "Other-design study \u2014 patient exposure \u2014 mean duration \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1346657533", "alias": "Other-design study \u2014 patient exposure \u2014 mean duration \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1355495822", "alias": "Other-design study \u2014 patient exposure \u2014 mean duration \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1471689963", "alias": "Other-design study \u2014 patient exposure \u2014 median duration \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1795005135", "alias": "Other-design study \u2014 patient exposure \u2014 median duration \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1649833708", "alias": "Other-design study \u2014 patient exposure \u2014 median duration \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "865332055", "alias": "Other-design study \u2014 patient exposure \u2014 median duration \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "389055137", "alias": "Other-design study \u2014 patient exposure \u2014 adherence \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "597889712", "alias": "Other-design study \u2014 patient exposure \u2014 adherence \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1290928538", "alias": "Other-design study \u2014 patient exposure \u2014 adherence \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1733181354", "alias": "Other-design study \u2014 patient exposure \u2014 adherence \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1342977823", "alias": "Other-design study \u2014 subsequent treatment \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "2091568375", "alias": "Other-design study \u2014 subsequent treatment \u2014 Study 1 treatment 1 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "853764126", "alias": "Other-design study \u2014 subsequent treatment \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1834059550", "alias": "Other-design study \u2014 subsequent treatment \u2014 Study 1 treatment 2 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1061093961", "alias": "Other-design study \u2014 subsequent treatment \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "504541961", "alias": "Other-design study \u2014 subsequent treatment \u2014 Study 2 treatment 1 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "684564564", "alias": "Other-design study \u2014 subsequent treatment \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1102746211", "alias": "Other-design study \u2014 subsequent treatment \u2014 Study 2 treatment 2 sample size", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "760827145", "alias": "Other-design study \u2014 subsequent treatment \u2014 received subsequent therapy \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1928443185", "alias": "Other-design study \u2014 subsequent treatment \u2014 received subsequent therapy \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "607463740", "alias": "Other-design study \u2014 subsequent treatment \u2014 received subsequent therapy \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "796055083", "alias": "Other-design study \u2014 subsequent treatment \u2014 received subsequent therapy \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "286853833", "alias": "Other-design study \u2014 subsequent treatment \u2014 therapy 1 name", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1772665119", "alias": "Other-design study \u2014 subsequent treatment \u2014 therapy 1 \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "2030648041", "alias": "Other-design study \u2014 subsequent treatment \u2014 therapy 1 \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "695583554", "alias": "Other-design study \u2014 subsequent treatment \u2014 therapy 1 \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "564217847", "alias": "Other-design study \u2014 subsequent treatment \u2014 therapy 1 \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "807513333", "alias": "Other-design study \u2014 subsequent treatment \u2014 therapy 2 name", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "2090568739", "alias": "Other-design study \u2014 subsequent treatment \u2014 therapy 2 \u2014 Study 1 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1720141317", "alias": "Other-design study \u2014 subsequent treatment \u2014 therapy 2 \u2014 Study 1 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "701151610", "alias": "Other-design study \u2014 subsequent treatment \u2014 therapy 2 \u2014 Study 2 treatment 1", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "1674083465", "alias": "Other-design study \u2014 subsequent treatment \u2014 therapy 2 \u2014 Study 2 treatment 2", "group": "Other-design study", "state": "answered", "chars": 51, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional study reported. [CSR PDF pp. 1,35-36]" }, { "id": "41185733", "alias": "Other-design results \u2014 efficacy endpoint 2 heading", "group": "Other-design results", "state": "answered", "chars": 120, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional gap-addressing study is reported in this CSR; its scope is the STEP 1 main phase. [CSR PDF pp. 1,32,35-36]" }, { "id": "354599696", "alias": "Other-design results \u2014 efficacy endpoint 3 heading", "group": "Other-design results", "state": "answered", "chars": 120, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional gap-addressing study is reported in this CSR; its scope is the STEP 1 main phase. [CSR PDF pp. 1,32,35-36]" }, { "id": "1400233702", "alias": "Other-design study \u2014 study ID (results heading)", "group": "Other-design study", "state": "answered", "chars": 120, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional gap-addressing study is reported in this CSR; its scope is the STEP 1 main phase. [CSR PDF pp. 1,32,35-36]" }, { "id": "318887612", "alias": "Other-design results \u2014 efficacy endpoint 1 heading", "group": "Other-design results", "state": "answered", "chars": 120, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 1, "text": "No additional gap-addressing study is reported in this CSR; its scope is the STEP 1 main phase. [CSR PDF pp. 1,32,35-36]" }, { "id": "264985966", "alias": "Economic evaluation \u2014 drug under review", "group": "Economic evaluation", "state": "answered", "chars": 317, "cited_pages": [ 39, 40 ], "sentence_checks": [ { "cited": 39, "best": 39, "score": 2, "delta": 0 } ], "numbers": { "1.0": "on_cited_page", "2.4": "on_cited_page", "3.0": "on_cited_page" }, "bracket_cites": 1, "text": "Semaglutide 2.4 mg once weekly, subcutaneous solution for injection. Trial products: 1.0 and 3.0 mg/mL in a 3 mL PDS290 pre-filled pen-injector. [CSR PDF pp. 39-40; Table 9-1] The Wegovy brand and marketed Canadian presentations are not established in this CSR. Canadian recommended monograph regimen is not supplied." }, { "id": "773279463", "alias": "Economic evaluation \u2014 submitted price", "group": "Economic evaluation", "state": "not_in_csr", "chars": 77, "text": "Not reported in the supplied CSR: no sponsor economic evaluation is provided.", "csr_pages_with_field_terms": 0 }, { "id": "1348867574", "alias": "Economic evaluation \u2014 regimen", "group": "Economic evaluation", "state": "answered", "chars": 624, "cited_pages": [ 39, 40, 41, 42 ], "sentence_checks": [ { "cited": 39, "best": 61, "score": 2, "delta": 22 } ], "numbers": { "0.25": "on_cited_page", "2.4": "on_cited_page", "500": "on_cited_page", "0.5": "on_cited_page", "150": "on_cited_page", "1.0": "on_cited_page", "1.7": "on_cited_page" }, "bracket_cites": 2, "text": "Economic-model regimen is not reported. Trial regimen: 0.25 mg once weekly for 4 weeks, then 0.5, 1.0 and 1.7 mg once weekly for 4 weeks each, then 2.4 mg once weekly for 52 weeks (68 weeks total). If 2.4 mg was not tolerated, 1.7 mg was permitted to avoid complete discontinuation, with an attempt to re-escalate recommended. [CSR PDF pp. 39-40; Tables 9-1 and 9-2] Matched placebo injection once weekly using the same pen and escalating volumes for 68 weeks; both groups received diet counselling targeting a 500 kcal/day deficit and \u2265150 minutes/week physical activity, with counselling every 4 we" }, { "id": "1289662293", "alias": "Economic evaluation \u2014 acquisition cost", "group": "Economic evaluation", "state": "not_in_csr", "chars": 77, "text": "Not reported in the supplied CSR: no sponsor economic evaluation is provided.", "csr_pages_with_field_terms": 0 }, { "id": "791844239", "alias": "Economic evaluation \u2014 type of economic evaluation", "group": "Economic evaluation", "state": "not_in_csr", "chars": 77, "text": "Not reported in the supplied CSR: no sponsor economic evaluation is provided.", "csr_pages_with_field_terms": 45 }, { "id": "2025125224", "alias": "Economic evaluation \u2014 treatment", "group": "Economic evaluation", "state": "not_in_csr", "chars": 294, "text": "Model treatment is not reported. Semaglutide 2.4 mg once weekly, subcutaneous solution for injection. Trial products: 1.0 and 3.0 mg/mL in a 3 mL PDS290 pre-filled pen-injector. [CSR PDF pp. 39-40; Table 9-1] The Wegovy brand and marketed Canadian presentations are not established in this CSR.", "csr_pages_with_field_terms": 33 }, { "id": "907116021", "alias": "Economic evaluation \u2014 included comparators", "group": "Economic evaluation", "state": "not_in_csr", "chars": 295, "text": "Model comparator(s) are not reported. Matched placebo injection once weekly using the same pen and escalating volumes for 68 weeks; both groups received diet counselling targeting a 500 kcal/day deficit and \u2265150 minutes/week physical activity, with counselling every 4 weeks. [CSR PDF pp. 39-42]", "csr_pages_with_field_terms": 14 }, { "id": "1495586639", "alias": "Economic evaluation \u2014 perspective", "group": "Economic evaluation", "state": "not_in_csr", "chars": 77, "text": "Not reported in the supplied CSR: no sponsor economic evaluation is provided.", "csr_pages_with_field_terms": 0 }, { "id": "361803547", "alias": "Economic evaluation \u2014 time horizon", "group": "Economic evaluation", "state": "not_in_csr", "chars": 77, "text": "Not reported in the supplied CSR: no sponsor economic evaluation is provided.", "csr_pages_with_field_terms": 9 }, { "id": "2131547341", "alias": "Economic evaluation \u2014 cycle length", "group": "Economic evaluation", "state": "not_in_csr", "chars": 77, "text": "Not reported in the supplied CSR: no sponsor economic evaluation is provided.", "csr_pages_with_field_terms": 0 }, { "id": "1891807567", "alias": "Economic evaluation \u2014 modelled populations", "group": "Economic evaluation", "state": "not_in_csr", "chars": 318, "text": "Model population is not reported. Trial population: Adults \u226518 years with BMI \u226530 kg/m\u00b2, or \u226527 kg/m\u00b2 with \u22651 treated or untreated weight-related comorbidity (hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease), and \u22651 self-reported unsuccessful dietary weight-loss effor", "csr_pages_with_field_terms": 0 }, { "id": "55874670", "alias": "Economic evaluation \u2014 modelled population characteristics", "group": "Economic evaluation", "state": "not_in_csr", "chars": 174, "text": "Model starting characteristics are not reported. Trial overall baseline: age 46 (SD 13) years; female 74.1%; weight 105.3 (21.9) kg; BMI 37.9 (6.7) kg/m\u00b2. [CSR PDF pp. 68-70]", "csr_pages_with_field_terms": 9 }, { "id": "758313764", "alias": "Economic evaluation \u2014 model health states", "group": "Economic evaluation", "state": "not_in_csr", "chars": 77, "text": "Not reported in the supplied CSR: no sponsor economic evaluation is provided.", "csr_pages_with_field_terms": 7 }, { "id": "1190394190", "alias": "Economic evaluation \u2014 duration of treatment", "group": "Economic evaluation", "state": "not_in_csr", "chars": 114, "text": "Model treatment duration is not reported. Trial treatment: 68 weeks, with 7-week safety follow-up. [CSR PDF p. 35]", "csr_pages_with_field_terms": 52 }, { "id": "706725562", "alias": "Economic evaluation \u2014 comparative efficacy sources", "group": "Economic evaluation", "state": "answered", "chars": 713, "cited_pages": [ 87, 333 ], "sentence_checks": [], "numbers": { "68,": "on_cited_page", "-5.10": "on_cited_page", "1.18": "on_cited_page", "11.08": "on_cited_page", "-12.44": "on_cited_page", "15%": "on_cited_page", "1306": "on_cited_page", "-14.85%": "on_cited_page", "9.43": "on_cited_page", "-8.53": "on_cited_page", "-6.34": "on_cited_page", "1212": "on_cited_page", "12.89": "on_cited_page", "-2.41%": "on_cited_page", "2.42": "on_cited_page", "1.80": "on_cited_page", "11.35": "on_cited_page", "577": "on_cited_page", "95%": "on_cited_page", "19.26": "on_cited_page", "-11.51": "on_cited_page", "0.0001": "elsewhere", "655": "on_cited_page", "-13.37": "on_cited_page", "-3.87": "on_cited_page", "28.76": "on_cited_page", "7.50": "on_cited_page", "14.68": "on_cited_page", "-10.30": "on_cited_page", "10%": "on_cited_page", "-9.42": "on_cited_page", "19.44": "on_cited_page" }, "bracket_cites": 2, "text": "Economic-model selection, assumptions and extrapolation are not reported. Available trial evidence: At week 68, treatment-policy estimated weight change was -14.85% with semaglutide and -2.41% with placebo: difference -12.44 percentage points (95% CI -13.37 to -11.51), p<0.0001. FAS n=1306/655; observed week-68 weight n=1212/577. [CSR PDF p. 333; Table 14.2.9] Confirmatory week-68 treatment-policy differences: waist -9.42 cm (95% CI -10.30 to -8.53), systolic BP -5.10 mmHg (-6.34 to -3.87), SF-36 physical functioning +1.80 (1.18-2.42), IWQOL physical function +9.43 (7.50-11.35); all p<0." }, { "id": "508644034", "alias": "Economic evaluation \u2014 natural history sources", "group": "Economic evaluation", "state": "answered", "chars": 784, "cited_pages": [ 31 ], "sentence_checks": [ { "cited": 31, "best": 31, "score": 13, "delta": 0 } ], "numbers": { "-10%": "on_cited_page", "5%": "on_cited_page" }, "bracket_cites": 1, "text": "Model natural-history inputs/transition assumptions are not reported. Obesity is described as a disease with substantial medical, societal and economic impact, reduced health-related quality of life, and increased morbidity and mortality. Associated complications include type 2 diabetes, hypertension, dyslipidaemia, sleep apnoea, cardiovascular disease, osteoarthritis, urinary incontinence, non-alcoholic steatohepatitis and some cancers. Risk increases with BMI; 5%-10% weight loss can improve comorbidities, physical symptoms and quality of life. Lifestyle-induced weight loss is opposed by incr" }, { "id": "635493110", "alias": "Economic evaluation \u2014 utilities sources", "group": "Economic evaluation", "state": "not_in_csr", "chars": 193, "text": "Health-state utility/disutility values and mapping are not reported. The CSR reports SF-36 and IWQOL-Lite-CT HRQoL measures; these should not be substituted for utilities. [CSR PDF pp. 112-120]", "csr_pages_with_field_terms": 1 }, { "id": "1000818579", "alias": "Economic evaluation \u2014 cost sources", "group": "Economic evaluation", "state": "not_in_csr", "chars": 77, "text": "Not reported in the supplied CSR: no sponsor economic evaluation is provided.", "csr_pages_with_field_terms": 1 }, { "id": "909304935", "alias": "Economic evaluation \u2014 base case results", "group": "Economic evaluation", "state": "not_in_csr", "chars": 77, "text": "Not reported in the supplied CSR: no sponsor economic evaluation is provided.", "csr_pages_with_field_terms": 21 }, { "id": "314227250", "alias": "Economic evaluation \u2014 scenario analysis results", "group": "Economic evaluation", "state": "not_in_csr", "chars": 77, "text": "Not reported in the supplied CSR: no sponsor economic evaluation is provided.", "csr_pages_with_field_terms": 31 }, { "id": "390713565", "alias": "Excluded studies \u2014 reference 1", "group": "Excluded studies", "state": "not_in_csr", "chars": 106, "text": "Not reported in the supplied CSR: no systematic literature search or review-selection process is provided.", "csr_pages_with_field_terms": 0 }, { "id": "750533216", "alias": "Excluded studies \u2014 reason 1", "group": "Excluded studies", "state": "not_in_csr", "chars": 106, "text": "Not reported in the supplied CSR: no systematic literature search or review-selection process is provided.", "csr_pages_with_field_terms": 2 } ] }