{ "summary": { "structure": { "blank": { "controls": 803, "tables": 32, "paragraphs": 1963, "chars": 45299 }, "chatgpt": { "controls": 965, "tables": 32, "paragraphs": 2001, "chars": 98647 } }, "states": { "answered": 245, "not_in_csr": 557 }, "silent_fields_with_field_terms_on_some_csr_page": 0, "not_in_csr_fields_with_field_terms_on_some_csr_page": 495, "answered": 245, "answers_with_bracketed_csr_cites_in_field_text": 0, "sentence_page_checks": { "checked": 0, "cited_page_is_best_match": 0, "within_2_pages": 0, "off_by_more_than_2": 0 }, "numbers": { "on_cited_page": 406, "elsewhere": 107 }, "numbers_not_in_csr_examples": [], "cross_run_ui_vs_api_batched": { "answered|missing": 245, "not_in_csr|missing": 557 }, "groups": { "Long-term extension": { "answered": 2, "not_in_csr": 111 }, "Key efficacy outcomes": { "answered": 22, "not_in_csr": 63 }, "Other-design study": { "not_in_csr": 74 }, "Systematic review": { "answered": 57, "not_in_csr": 1 }, "Indirect comparison": { "not_in_csr": 55 }, "Patient disposition": { "answered": 26, "not_in_csr": 24 }, "Estimated prevalence": { "not_in_csr": 42 }, "Efficacy outcome sample": { "answered": 14, "not_in_csr": 26 }, "Included studies": { "answered": 17, "not_in_csr": 21 }, "Patient exposure": { "answered": 10, "not_in_csr": 14 }, "Subsequent treatment": { "not_in_csr": 14, "answered": 10 }, "Baseline characteristics": { "answered": 13, "not_in_csr": 10 }, "Economic evaluation": { "not_in_csr": 20 }, "Comparators": { "answered": 6, "not_in_csr": 8 }, "Statistical analysis": { "answered": 10, "not_in_csr": 4 }, "Reimbursement conditions": { "not_in_csr": 12, "answered": 1 }, "Analysis populations": { "answered": 9, "not_in_csr": 3 }, "Summary of outcomes": { "answered": 6, "not_in_csr": 2 }, "Inclusion criteria": { "answered": 4, "not_in_csr": 3 }, "Long-term": { "answered": 2, "not_in_csr": 4 }, "Place in therapy": { "answered": 2, "not_in_csr": 3 }, "Review protocol PICO": { "not_in_csr": 2, "answered": 3 }, "Drug under review": { "not_in_csr": 2, "answered": 2 }, "Evidence gaps": { "answered": 1, "not_in_csr": 2 }, "Other-design results": { "not_in_csr": 3 }, "Disease background": { "answered": 1, "not_in_csr": 1 }, "Diagnosis": { "not_in_csr": 2 }, "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": { "not_in_csr": 1 } } }, "rows": [ { "id": "666065098", "alias": "List of Tables", "group": "List of Tables", "state": "answered", "chars": 1836, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Table 1: Submitted for Review ; Table 2: Sample table for presenting the estimated prevalence in each region; Table 3: Key characteristics of Drug 1, Drug 2, etc.; Table 4: Proposed Reimbursement Conditions for the Drug Under Review; Table 5: Inclusion criteria for the systematic review; Table 6: Details of Included Studies; Table 7: Summary of Outcomes Relevant to the Systematic Review ; Table 8: Statistical Analysis of Efficacy Endpoints; Table 9: Analysis Populations of Study 1 and Study 2; Table 10: Summary of Baseline Characteristics of Study 1 and Study 2; Table 11: Sample Table for Pati" }, { "id": "880393120", "alias": "List of figures", "group": "List of figures", "state": "not_in_csr", "chars": 122, "text": "No clinical figures added. Figure fields are retained and marked where the source does not provide the requested evidence.", "csr_pages_with_field_terms": null }, { "id": "1792627528", "alias": "Abbreviations", "group": "Abbreviations", "state": "answered", "chars": 481, "cited_pages": [ 25, 26 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "ANCOVA = analysis of covariance; BMI = body mass index; CSR = clinical study report; DXA/DEXA = dual-energy X-ray absorptiometry; ETD = estimated treatment difference; GLP-1 = glucagon-like peptide-1; HbA1c = glycated haemoglobin; IWQOL-Lite-CT = Impact of Weight on Quality of Life-Lite for Clinical Trials; MMRM = mixed model for repeated measurements; OR = odds ratio; PRO = patient-reported outcome; SAS = safety analysis set; SF-36 = Short Form-36. (CSR pp. 25-26, 45-46, 58.)" }, { "id": "198338343", "alias": "Drug under review \u2014 product identification", "group": "Drug under review", "state": "not_in_csr", "chars": 155, "text": "Semaglutide, solution for subcutaneous injection, maintenance dose 2.4 mg once weekly. The brand name Wegovy is not stated in this CSR. (CSR pp. 2, 39-40.)", "csr_pages_with_field_terms": 3 }, { "id": "538565650", "alias": "Sponsor name", "group": "Sponsor name", "state": "answered", "chars": 61, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "2880": "on_cited_page" }, "bracket_cites": 0, "text": "Novo Nordisk, Novo All\u00e9, 2880 Bagsvaerd, Denmark. (CSR p. 2.)" }, { "id": "767926277", "alias": "Health Canada indication", "group": "Health Canada indication", "state": "not_in_csr", "chars": 71, "text": "Not reported in the supplied CSR. (CSR pp. 1, 32, 35-36: report scope.)", "csr_pages_with_field_terms": 2 }, { "id": "1109251318", "alias": "Health Canada approval status", "group": "Health Canada approval status", "state": "not_in_csr", "chars": 71, "text": "Not reported in the supplied CSR. (CSR pp. 1, 32, 35-36: report scope.)", "csr_pages_with_field_terms": 29 }, { "id": "1069967496", "alias": "Health Canada review pathway", "group": "Health Canada review pathway", "state": "not_in_csr", "chars": 71, "text": "Not reported in the supplied CSR. (CSR pp. 1, 32, 35-36: report scope.)", "csr_pages_with_field_terms": 1 }, { "id": "1427308873", "alias": "NOC date", "group": "NOC date", "state": "not_in_csr", "chars": 71, "text": "Not reported in the supplied CSR. (CSR pp. 1, 32, 35-36: report scope.)", "csr_pages_with_field_terms": null }, { "id": "631054096", "alias": "Mechanism of action", "group": "Mechanism of action", "state": "answered", "chars": 227, "cited_pages": [ 31, 32 ], "sentence_checks": [], "numbers": { "94%": "on_cited_page" }, "bracket_cites": 0, "text": "Semaglutide is a long-acting, selective GLP-1 receptor agonist with 94% homology to human GLP-1. Weight reduction is mediated mainly through reduced energy intake, increased satiety/fullness and reduced hunger. (CSR pp. 31-32.)" }, { "id": "1517267069", "alias": "Recommended dosage", "group": "Recommended dosage", "state": "not_in_csr", "chars": 321, "text": "Trial regimen: semaglutide subcutaneously once weekly, 0.25, 0.5, 1.0 and 1.7 mg for 4 weeks each, then 2.4 mg for 52 weeks. A 1.7 mg maintenance dose was permitted for intolerance, with an attempt to re-escalate recommended. (CSR pp. 39-40, Tables 9-1 and 9-2.) Approved Canadian dosing is not repor", "csr_pages_with_field_terms": 0 }, { "id": "1971185590", "alias": "Submission type", "group": "Submission type", "state": "not_in_csr", "chars": 71, "text": "Not reported in the supplied CSR. (CSR pp. 1, 32, 35-36: report scope.)", "csr_pages_with_field_terms": 0 }, { "id": "1224595166", "alias": "Reimbursement request", "group": "Reimbursement request", "state": "not_in_csr", "chars": 71, "text": "Not reported in the supplied CSR. (CSR pp. 1, 32, 35-36: report scope.)", "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": 71, "text": "Not reported in the supplied CSR. (CSR pp. 1, 32, 35-36: report scope.)", "csr_pages_with_field_terms": 0 }, { "id": "80408254", "alias": "Indication and reimbursement request", "group": "Indication and reimbursement request", "state": "not_in_csr", "chars": 174, "text": "The CSR describes weight management in adults with overweight or obesity; it does not provide the Health Canada indication or a reimbursement request. (CSR pp. 2, 32, 36-37.)", "csr_pages_with_field_terms": 0 }, { "id": "230650760", "alias": "Drug under review \u2014 dosing and administration", "group": "Drug under review", "state": "answered", "chars": 427, "cited_pages": [ 39, 40, 41 ], "sentence_checks": [], "numbers": { "0.25": "on_cited_page", "1.7": "on_cited_page", "500": "on_cited_page", "1.0": "on_cited_page", "0.5": "on_cited_page", "150": "on_cited_page", "2.4": "on_cited_page" }, "bracket_cites": 0, "text": "Trial regimen: semaglutide subcutaneously once weekly, 0.25, 0.5, 1.0 and 1.7 mg for 4 weeks each, then 2.4 mg for 52 weeks. A 1.7 mg maintenance dose was permitted for intolerance, with an attempt to re-escalate recommended. (CSR pp. 39-40, Tables 9-1 and 9-2.) Both groups received counselling every 4 weeks for a 500 kcal/day deficit and \u2265150 minutes/week of physical activity, with daily food/activity records. (CSR p. 41.)" }, { "id": "600835751", "alias": "Drug under review \u2014 mechanism of action", "group": "Drug under review", "state": "answered", "chars": 227, "cited_pages": [ 31, 32 ], "sentence_checks": [], "numbers": { "94%": "on_cited_page" }, "bracket_cites": 0, "text": "Semaglutide is a long-acting, selective GLP-1 receptor agonist with 94% homology to human GLP-1. Weight reduction is mediated mainly through reduced energy intake, increased satiety/fullness and reduced hunger. (CSR pp. 31-32.)" }, { "id": "1321906422", "alias": "Drug under review \u2014 prescribing restrictions", "group": "Drug under review", "state": "not_in_csr", "chars": 195, "text": "Trial injections were self-administered once weekly in the thigh, abdomen or upper arm, at any time regardless of meals. Canadian prescriber restrictions are not reported. (CSR p. 40, Table 9-1.)", "csr_pages_with_field_terms": 0 }, { "id": "1010375957", "alias": "Disease background \u2014 overview of condition", "group": "Disease background", "state": "answered", "chars": 339, "cited_pages": [ 31 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Obesity is associated with increased morbidity, mortality and reduced health-related quality of life; associated conditions include type 2 diabetes, hypertension, dyslipidaemia, sleep apnoea, cardiovascular disease and osteoarthritis. The CSR describes difficulty achieving and maintaining weight loss with lifestyle measures. (CSR p. 31.)" }, { "id": "1862541793", "alias": "Disease background \u2014 estimated disease prevalence narrative", "group": "Disease background", "state": "not_in_csr", "chars": 169, "text": "Canadian provincial/territorial prevalence estimates and uncertainty bounds are not reported. The CSR provides a qualitative global obesity background only. (CSR p. 31.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 3 }, { "id": "862513230", "alias": "Estimated prevalence \u2014 Alberta \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 5 }, { "id": "399868640", "alias": "Estimated prevalence \u2014 Alberta \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 2 }, { "id": "1049388599", "alias": "Estimated prevalence \u2014 Alberta \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 3 }, { "id": "707348494", "alias": "Estimated prevalence \u2014 Manitoba \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 5 }, { "id": "1054949687", "alias": "Estimated prevalence \u2014 Manitoba \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 2 }, { "id": "471519582", "alias": "Estimated prevalence \u2014 Manitoba \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 3 }, { "id": "1164403495", "alias": "Estimated prevalence \u2014 Nunavut \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 5 }, { "id": "1818044526", "alias": "Estimated prevalence \u2014 Nunavut \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 2 }, { "id": "1638920587", "alias": "Estimated prevalence \u2014 Nunavut \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 3 }, { "id": "523553245", "alias": "Estimated prevalence \u2014 Ontario \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 5 }, { "id": "1576426057", "alias": "Estimated prevalence \u2014 Ontario \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 2 }, { "id": "857628237", "alias": "Estimated prevalence \u2014 Ontario \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 3 }, { "id": "50866461", "alias": "Estimated prevalence \u2014 Saskatchewan \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 5 }, { "id": "1870012319", "alias": "Estimated prevalence \u2014 Saskatchewan \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 2 }, { "id": "1477188374", "alias": "Estimated prevalence \u2014 Saskatchewan \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 3 }, { "id": "1187982909", "alias": "Estimated prevalence \u2014 Yukon \u2014 lower estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 5 }, { "id": "1237249317", "alias": "Estimated prevalence \u2014 Yukon \u2014 best estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 2 }, { "id": "1079986308", "alias": "Estimated prevalence \u2014 Yukon \u2014 upper estimate", "group": "Estimated prevalence", "state": "not_in_csr", "chars": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "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": 38, "text": "Not reported. (CSR p. 31: background.)", "csr_pages_with_field_terms": 7 }, { "id": "1333223319", "alias": "Diagnosis \u2014 diagnostic testing requirements", "group": "Diagnosis", "state": "not_in_csr", "chars": 263, "text": "Trial assessment included body weight, height/BMI, waist circumference and laboratory measures including HbA1c and fasting plasma glucose; HbA1c \u22656.5% was a key exclusion. Requirements for routine Canadian diagnostic testing are not reported. (CSR pp. 37, 45-46.)", "csr_pages_with_field_terms": 4 }, { "id": "804539857", "alias": "Diagnosis \u2014 availability of diagnostic testing", "group": "Diagnosis", "state": "not_in_csr", "chars": 177, "text": "Central and specialized laboratories were used in the trial; availability, access barriers and coverage of diagnostic testing in Canadian practice are not reported. (CSR p. 29.)", "csr_pages_with_field_terms": 1 }, { "id": "193925407", "alias": "Health Care Resources - Pre-treatment phase", "group": "Health Care Resources", "state": "not_in_csr", "chars": 185, "text": "Trial screening assessed eligibility and included a food diary and mental-health randomization criteria. Canadian pre-treatment resource use and costs are not reported. (CSR pp. 37-38.)", "csr_pages_with_field_terms": 3 }, { "id": "1753192794", "alias": "Health care resources \u2014 treatment phase", "group": "Health care resources", "state": "not_in_csr", "chars": 314, "text": "Both groups received counselling every 4 weeks for a 500 kcal/day deficit and \u2265150 minutes/week of physical activity, with daily food/activity records. (CSR p. 41.) Trial use of injections and safety assessments is described, but routine-care resource quantities and costs are not reported. (CSR pp. ", "csr_pages_with_field_terms": 21 }, { "id": "1278843648", "alias": "Health Care Resources - Post-treatment phase", "group": "Health Care Resources", "state": "not_in_csr", "chars": 153, "text": "A safety follow-up visit was scheduled 7 weeks after treatment; routine Canadian post-treatment resource use and costs are not reported. (CSR pp. 35-36.)", "csr_pages_with_field_terms": 4 }, { "id": "1769136716", "alias": "Place in therapy \u2014 current treatment paradigm", "group": "Place in therapy", "state": "answered", "chars": 275, "cited_pages": [ 31 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "The CSR describes lifestyle intervention (diet and exercise) as first-line treatment, bariatric surgery as an option for some people with severe obesity, and pharmacotherapy as a potential alternative. It does not set out a Canadian reimbursement algorithm. (CSR pp. 31, 36.)" }, { "id": "313885677", "alias": "Place in therapy \u2014 unmet therapeutic needs", "group": "Place in therapy", "state": "answered", "chars": 239, "cited_pages": [ 31 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "The CSR identifies difficulty sustaining weight loss, biological responses promoting regain, limitations of surgery and a need for safe, effective, convenient therapies supporting weight maintenance and comorbidity management. (CSR p. 31.)" }, { "id": "703979793", "alias": "Place in therapy \u2014 proposed place in therapy", "group": "Place in therapy", "state": "not_in_csr", "chars": 300, "text": "Adults aged \u226518 years with BMI \u226530 kg/m\u00b2, or \u226527 kg/m\u00b2 with hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease, and \u22651 unsuccessful dietary weight-loss effort; type 2 diabetes excluded. (CSR pp. 36-37.) Canadian reimbursement positioning is not reported. (CSR pp. 32-37.)", "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": 149, "text": "Effects on utilization, displacement or funding of currently reimbursed treatments are not reported. (CSR pp. 31-37: trial rationale and comparator.)", "csr_pages_with_field_terms": 5 }, { "id": "1892960731", "alias": "Provisional algorithm diagram - description", "group": "Provisional algorithm diagram", "state": "not_in_csr", "chars": 116, "text": "Not applicable to this weight-management trial; an oncology treatment algorithm is not reported. (CSR pp. 2, 32-37.)", "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": 116, "text": "Not applicable to this weight-management trial; an oncology treatment algorithm is not reported. (CSR pp. 2, 32-37.)", "csr_pages_with_field_terms": 1 }, { "id": "1759026699", "alias": "Comparators description", "group": "Comparators description", "state": "answered", "chars": 167, "cited_pages": [ 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "The randomized comparator was matching subcutaneous placebo plus the same lifestyle intervention. No active-comparator randomized arm is reported. (CSR pp. 37, 39-41.)" }, { "id": "284852098", "alias": "Comparators \u2014 drug under review name", "group": "Comparators", "state": "answered", "chars": 25, "cited_pages": [ 40 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Semaglutide. (CSR p. 40.)" }, { "id": "1583495440", "alias": "Comparators \u2014 drug under review indication", "group": "Comparators", "state": "not_in_csr", "chars": 76, "text": "Trial: weight management; Canadian indication not reported. (CSR pp. 2, 37.)", "csr_pages_with_field_terms": 0 }, { "id": "1189929439", "alias": "Comparators \u2014 drug under review regimen", "group": "Comparators", "state": "answered", "chars": 262, "cited_pages": [ 39, 40 ], "sentence_checks": [], "numbers": { "0.25": "on_cited_page", "1.7": "on_cited_page", "1.0": "on_cited_page", "0.5": "on_cited_page", "2.4": "on_cited_page" }, "bracket_cites": 0, "text": "Trial regimen: semaglutide subcutaneously once weekly, 0.25, 0.5, 1.0 and 1.7 mg for 4 weeks each, then 2.4 mg for 52 weeks. A 1.7 mg maintenance dose was permitted for intolerance, with an attempt to re-escalate recommended. (CSR pp. 39-40, Tables 9-1 and 9-2.)" }, { "id": "1472527722", "alias": "Comparators \u2014 comparator 1 name", "group": "Comparators", "state": "answered", "chars": 30, "cited_pages": [ 40 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Matching placebo. (CSR p. 40.)" }, { "id": "351979935", "alias": "Comparators \u2014 comparator 1 indication", "group": "Comparators", "state": "answered", "chars": 44, "cited_pages": [ 37 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Control intervention in STEP 1. (CSR p. 37.)" }, { "id": "1248902499", "alias": "Comparators \u2014 comparator 1 regimen", "group": "Comparators", "state": "answered", "chars": 128, "cited_pages": [ 39, 40, 41 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Subcutaneous once weekly; volume matched to semaglutide escalation and maintenance; same lifestyle counselling. (CSR pp. 39-41.)" }, { "id": "2138645005", "alias": "Comparators \u2014 comparator 1 indirect comparison rationale", "group": "Comparators", "state": "not_in_csr", "chars": 120, "text": "Not reported in the supplied CSR: no indirect comparison is presented. (CSR pp. 32-37: direct placebo-controlled trial.)", "csr_pages_with_field_terms": 0 }, { "id": "1584295274", "alias": "Comparators \u2014 comparator 1 pharmacoeconomic evaluation rationale", "group": "Comparators", "state": "not_in_csr", "chars": 120, "text": "Not reported in the supplied CSR: no pharmacoeconomic submission is presented. (CSR pp. 1, 32-36: clinical-trial scope.)", "csr_pages_with_field_terms": 1 }, { "id": "56679918", "alias": "Comparators \u2014 comparator 2 name", "group": "Comparators", "state": "not_in_csr", "chars": 71, "text": "Not reported in the supplied CSR. (CSR pp. 1, 32, 35-36: report scope.)", "csr_pages_with_field_terms": 0 }, { "id": "1139272176", "alias": "Comparators \u2014 comparator 2 indication", "group": "Comparators", "state": "not_in_csr", "chars": 71, "text": "Not reported in the supplied CSR. (CSR pp. 1, 32, 35-36: report scope.)", "csr_pages_with_field_terms": 0 }, { "id": "1671645521", "alias": "Comparators \u2014 comparator 2 regimen", "group": "Comparators", "state": "not_in_csr", "chars": 71, "text": "Not reported in the supplied CSR. (CSR pp. 1, 32, 35-36: report scope.)", "csr_pages_with_field_terms": 0 }, { "id": "1471605575", "alias": "Comparators \u2014 comparator 2 indirect comparison rationale", "group": "Comparators", "state": "not_in_csr", "chars": 120, "text": "Not reported in the supplied CSR: no indirect comparison is presented. (CSR pp. 32-37: direct placebo-controlled trial.)", "csr_pages_with_field_terms": 0 }, { "id": "1117325907", "alias": "Comparators \u2014 comparator 2 pharmacoeconomic evaluation rationale", "group": "Comparators", "state": "not_in_csr", "chars": 120, "text": "Not reported in the supplied CSR: no pharmacoeconomic submission is presented. (CSR pp. 1, 32-36: clinical-trial scope.)", "csr_pages_with_field_terms": 1 }, { "id": "451938502", "alias": "Comparators \u2014 data sources", "group": "Comparators", "state": "answered", "chars": 151, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Source for completed entries: reference 1, STEP 1 CSR; specific page/table citations appear in each completed field. No other evidence source was used." }, { "id": "691662644", "alias": "Proposed reimbursement conditions", "group": "Proposed reimbursement conditions", "state": "not_in_csr", "chars": 213, "text": "Proposed initiation, renewal, discontinuation and prescribing reimbursement conditions and their rationales are not reported; trial eligibility and stopping rules are not reimbursement conditions. (CSR pp. 37-39.)", "csr_pages_with_field_terms": 0 }, { "id": "115541822", "alias": "Reimbursement conditions \u2014 initiation condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 1 }, { "id": "1440032977", "alias": "Reimbursement conditions \u2014 initiation rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 0 }, { "id": "1774983937", "alias": "Reimbursement conditions \u2014 initiation alignment condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 1 }, { "id": "1288836516", "alias": "Reimbursement conditions \u2014 initiation alignment rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 0 }, { "id": "198562177", "alias": "Reimbursement conditions \u2014 renewal condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 1 }, { "id": "1469981911", "alias": "Reimbursement conditions \u2014 renewal rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 0 }, { "id": "593079894", "alias": "Reimbursement conditions \u2014 renewal alignment condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 1 }, { "id": "181289987", "alias": "Reimbursement conditions \u2014 renewal alignment rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 0 }, { "id": "806644934", "alias": "Reimbursement conditions \u2014 discontinuation condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 3 }, { "id": "1088305840", "alias": "Reimbursement conditions \u2014 discontinuation rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 2 }, { "id": "1138168675", "alias": "Reimbursement conditions \u2014 prescribing condition", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 1 }, { "id": "1817405152", "alias": "Reimbursement conditions \u2014 prescribing rationale", "group": "Reimbursement conditions", "state": "not_in_csr", "chars": 93, "text": "Not reported in CSR: reimbursement condition/rationale. (CSR pp. 37-39: trial criteria only.)", "csr_pages_with_field_terms": 0 }, { "id": "1985672964", "alias": "Reimbursement conditions - Abbreviations", "group": "Reimbursement conditions", "state": "answered", "chars": 137, "cited_pages": [ 25, 26 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "AE = adverse event; CI = confidence interval; FAS = full analysis set; OR = odds ratio; SAE = serious adverse event. (CSR pp. 25-26, 58.)" }, { "id": "344607807", "alias": "Systematic review \u2014 objective", "group": "Systematic review", "state": "answered", "chars": 246, "cited_pages": [ 1 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "No systematic review is reported in the CSR. The available clinical evidence summarized here is STEP 1, whose primary objective was comparison of weight change with semaglutide versus placebo, both with lifestyle intervention. (CSR pp. 1, 32-33.)" }, { "id": "1711002088", "alias": "Review protocol PICO - Population", "group": "Review protocol PICO", "state": "not_in_csr", "chars": 318, "text": "Adults aged \u226518 years with BMI \u226530 kg/m\u00b2, or \u226527 kg/m\u00b2 with hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease, and \u22651 unsuccessful dietary weight-loss effort; type 2 diabetes excluded. (CSR pp. 36-37.) Systematic-review population criteria and subgroups are not reported", "csr_pages_with_field_terms": 5 }, { "id": "1669481612", "alias": "Review protocol PICO - Intervention", "group": "Review protocol PICO", "state": "answered", "chars": 262, "cited_pages": [ 39, 40 ], "sentence_checks": [], "numbers": { "0.25": "on_cited_page", "1.7": "on_cited_page", "1.0": "on_cited_page", "0.5": "on_cited_page", "2.4": "on_cited_page" }, "bracket_cites": 0, "text": "Trial regimen: semaglutide subcutaneously once weekly, 0.25, 0.5, 1.0 and 1.7 mg for 4 weeks each, then 2.4 mg for 52 weeks. A 1.7 mg maintenance dose was permitted for intolerance, with an attempt to re-escalate recommended. (CSR 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": 122, "text": "Matching placebo plus lifestyle intervention. Systematic-review comparator criteria are not reported. (CSR pp. 37, 39-41.)", "csr_pages_with_field_terms": 0 }, { "id": "350684775", "alias": "Review protocol PICO - Outcomes", "group": "Review protocol PICO", "state": "answered", "chars": 368, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": { "15%": "on_cited_page", "10%": "on_cited_page", "5%": "on_cited_page" }, "bracket_cites": 0, "text": "Co-primary: percentage change in body weight and \u22655% weight loss at week 68. Confirmatory secondary: \u226510% and \u226515% weight loss; changes in waist circumference, systolic blood pressure, SF-36 physical functioning and IWQOL-Lite-CT physical function at week 68. All eight endpoints were in the multiplicity-controlled hierarchy. (CSR pp. 59-61, 87, Tables 9-8 and 11-1.)" }, { "id": "909017236", "alias": "Review protocol PICO - Study design", "group": "Review protocol PICO", "state": "answered", "chars": 293, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "1,961": "elsewhere", "4373": "on_cited_page", "1,306": "elsewhere", "655": "elsewhere" }, "bracket_cites": 0, "text": "STEP 1 (NN9536-4373; NCT03548935) was a phase 3a, multicentre, multinational, randomized, double-blind, placebo-controlled trial; 1,961 participants were randomized 2:1 (semaglutide 1,306; placebo 655). It included 68 weeks of treatment and 7 weeks of safety follow-up. (CSR pp. 2, 35, 65-66.)" }, { "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": "5" }, { "id": "1880349076", "alias": "Inclusion criteria \u2014 population", "group": "Inclusion criteria", "state": "answered", "chars": 437, "cited_pages": [ 32, 37 ], "sentence_checks": [], "numbers": { "30.0": "on_cited_page", "27.0": "on_cited_page" }, "bracket_cites": 0, "text": "Male or female, age \u226518 years at informed consent; BMI \u226530.0 kg/m\u00b2, or \u226527.0 kg/m\u00b2 with at least one treated or untreated weight-related comorbidity (hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease); and at least one self-reported unsuccessful dietary effort to lose weight. (CSR p. 37.) The CSR describes STEP 1 eligibility, but does not provide systematic-review selection criteria. (CSR pp. 32, 36-37.)" }, { "id": "2015476795", "alias": "Inclusion criteria \u2014 relevant subgroups", "group": "Inclusion criteria", "state": "not_in_csr", "chars": 326, "text": "The prespecified DEXA sub-population required BMI \u226440.0 kg/m\u00b2 at screening and an acceptable-quality baseline scan confirmed by the imaging laboratory before randomization. It comprised 140 participants (95 semaglutide; 45 placebo). Systematic-review subgroup selection criteria are not reported. (CS", "csr_pages_with_field_terms": 11 }, { "id": "732486507", "alias": "Inclusion criteria \u2014 intervention", "group": "Inclusion criteria", "state": "answered", "chars": 262, "cited_pages": [ 39, 40 ], "sentence_checks": [], "numbers": { "0.25": "on_cited_page", "1.7": "on_cited_page", "1.0": "on_cited_page", "0.5": "on_cited_page", "2.4": "on_cited_page" }, "bracket_cites": 0, "text": "Trial regimen: semaglutide subcutaneously once weekly, 0.25, 0.5, 1.0 and 1.7 mg for 4 weeks each, then 2.4 mg for 52 weeks. A 1.7 mg maintenance dose was permitted for intolerance, with an attempt to re-escalate recommended. (CSR pp. 39-40, Tables 9-1 and 9-2.)" }, { "id": "724565510", "alias": "Inclusion criteria \u2014 comparators", "group": "Inclusion criteria", "state": "not_in_csr", "chars": 122, "text": "Matching placebo plus lifestyle intervention. Systematic-review comparator criteria are not reported. (CSR pp. 37, 39-41.)", "csr_pages_with_field_terms": 11 }, { "id": "701037126", "alias": "Inclusion criteria \u2014 efficacy outcomes", "group": "Inclusion criteria", "state": "answered", "chars": 368, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": { "15%": "on_cited_page", "10%": "on_cited_page", "5%": "on_cited_page" }, "bracket_cites": 0, "text": "Co-primary: percentage change in body weight and \u22655% weight loss at week 68. Confirmatory secondary: \u226510% and \u226515% weight loss; changes in waist circumference, systolic blood pressure, SF-36 physical functioning and IWQOL-Lite-CT physical function at week 68. All eight endpoints were in the multiplicity-controlled hierarchy. (CSR pp. 59-61, 87, Tables 9-8 and 11-1.)" }, { "id": "473002630", "alias": "Inclusion criteria \u2014 harms outcomes", "group": "Inclusion criteria", "state": "answered", "chars": 89, "cited_pages": [ 61 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "AEs, SAEs, fatal events, discontinuations, and safety focus areas. (CSR pp. 61, 128-129.)" }, { "id": "890642733", "alias": "Inclusion criteria \u2014 study designs", "group": "Inclusion criteria", "state": "not_in_csr", "chars": 361, "text": "STEP 1 (NN9536-4373; NCT03548935) was a phase 3a, multicentre, multinational, randomized, double-blind, placebo-controlled trial; 1,961 participants were randomized 2:1 (semaglutide 1,306; placebo 655). It included 68 weeks of treatment and 7 weeks of safety follow-up. (CSR pp. 2, 35, 65-66.) System", "csr_pages_with_field_terms": 11 }, { "id": "486984095", "alias": "PICO table - Abbreviations", "group": "PICO table", "state": "answered", "chars": 137, "cited_pages": [ 25, 26 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "AE = adverse event; CI = confidence interval; FAS = full analysis set; OR = odds ratio; SAE = serious adverse event. (CSR pp. 25-26, 58.)" }, { "id": "1663243863", "alias": "Literature search methodology", "group": "Literature search methodology", "state": "not_in_csr", "chars": 263, "text": "Systematic-review information not reported in supplied CSR. (CSR pp. 1, 32-36.)\n\n\nSearching bibliographic databases\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nSearching clinical trial registries\n\n\n\n\n\nReporting of the literature search\n\nExample of Reporting Clinical Literature Search Methods", "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": 52, "text": "Population search: not reported. (CSR pp. 1, 32-36.)", "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": 79, "text": "Systematic-review information not reported in supplied CSR. (CSR pp. 1, 32-36.)", "csr_pages_with_field_terms": 48 }, { "id": "1775098485", "alias": "PRISMA flow diagram \u2014 figure number", "group": "PRISMA flow diagram", "state": "not_in_csr", "chars": 12, "text": "Not reported", "csr_pages_with_field_terms": 1 }, { "id": "1281811044", "alias": "Study selection \u2014 PRISMA flow diagram", "group": "Study selection", "state": "not_in_csr", "chars": 79, "text": "Systematic-review information not reported in supplied CSR. (CSR pp. 1, 32-36.)", "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": "6" }, { "id": "917274444", "alias": "Included studies \u2014 Study 1 name", "group": "Included studies", "state": "answered", "chars": 33, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "4373": "on_cited_page" }, "bracket_cites": 0, "text": "STEP 1 / NN9536-4373. (CSR p. 2.)" }, { "id": "197412906", "alias": "Included studies \u2014 Study 2 name", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 3 }, { "id": "1930116000", "alias": "Included studies \u2014 Study 1 design", "group": "Included studies", "state": "answered", "chars": 293, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "1,961": "elsewhere", "4373": "on_cited_page", "1,306": "elsewhere", "655": "elsewhere" }, "bracket_cites": 0, "text": "STEP 1 (NN9536-4373; NCT03548935) was a phase 3a, multicentre, multinational, randomized, double-blind, placebo-controlled trial; 1,961 participants were randomized 2:1 (semaglutide 1,306; placebo 655). It included 68 weeks of treatment and 7 weeks of safety follow-up. (CSR pp. 2, 35, 65-66.)" }, { "id": "1565938690", "alias": "Included studies \u2014 Study 2 design", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 2 }, { "id": "1676867584", "alias": "Included studies \u2014 Study 1 locations", "group": "Included studies", "state": "answered", "chars": 261, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "129": "on_cited_page", "13,": "on_cited_page", "10,": "on_cited_page" }, "bracket_cites": 0, "text": "129 sites in 16 countries: Argentina 5, Belgium 5, Bulgaria 5, Canada 7, Denmark 1, Finland 2, France 7, Germany 13, India 13, Japan 5, Mexico 3, Poland 4, Russian Federation 8, Taiwan 1, UK 10, US 40. All sites screened and randomized participants. (CSR p. 2.)" }, { "id": "908712584", "alias": "Included studies \u2014 Study 2 locations", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 0 }, { "id": "1994652249", "alias": "Included studies \u2014 Study 1 enrolment start date", "group": "Included studies", "state": "answered", "chars": 42, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "2018": "on_cited_page" }, "bracket_cites": 0, "text": "4 June 2018 (trial initiated). (CSR p. 2.)" }, { "id": "933644844", "alias": "Included studies \u2014 Study 1 enrolment end date", "group": "Included studies", "state": "not_in_csr", "chars": 59, "text": "Last enrollment date not reported. (CSR p. 2: trial dates.)", "csr_pages_with_field_terms": 39 }, { "id": "756660477", "alias": "Included studies \u2014 Study 2 enrolment start date", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 42 }, { "id": "1664939013", "alias": "Included studies \u2014 Study 2 enrolment end date", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 39 }, { "id": "1838953778", "alias": "Included studies \u2014 Study 1 randomized enrolment", "group": "Included studies", "state": "answered", "chars": 161, "cited_pages": [ 35 ], "sentence_checks": [], "numbers": { "655": "elsewhere", "1,961": "elsewhere", "1,306": "elsewhere", "2.4": "on_cited_page" }, "bracket_cites": 0, "text": "Total randomized N = 1,961: semaglutide 2.4 mg N = 1,306; placebo N = 655 (2:1 allocation). All randomized participants received trial product. (CSR pp. 35, 65.)" }, { "id": "757931386", "alias": "Included studies \u2014 Study 2 randomized enrolment", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. 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(CSR pp. 1, 32.)", "csr_pages_with_field_terms": 25 }, { "id": "1338957035", "alias": "Included studies \u2014 Study 1 exclusion criteria", "group": "Included studies", "state": "answered", "chars": 521, "cited_pages": [ 36, 37, 38 ], "sentence_checks": [], "numbers": { "6.5%": "on_cited_page", "15,": "on_cited_page" }, "bracket_cites": 0, "text": "Key exclusions were HbA1c \u226548 mmol/mol (6.5%) at screening and self-reported body-weight change >5 kg within the previous 90 days; type 2 diabetes was excluded. (CSR pp. 36-37.) Other documented screen-failure criteria included uncontrolled thyroid disease, PHQ-9 score \u226515 and a lifetime suicide attempt. Randomization additionally required a food diary with at most 2 missed days, PHQ-9 <15, no suicidal behaviour, and no type 4 or 5 C-SSRS suicidal ideation between screening and randomization. (CSR pp. 38, 68.)" }, { "id": "1008430582", "alias": "Included studies \u2014 Study 2 exclusion criteria", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 27 }, { "id": "2066905324", "alias": "Included studies \u2014 Study 1 intervention regimen", "group": "Included studies", "state": "answered", "chars": 427, "cited_pages": [ 39, 40, 41 ], "sentence_checks": [], "numbers": { "0.25": "on_cited_page", "1.7": "on_cited_page", "500": "on_cited_page", "1.0": "on_cited_page", "0.5": "on_cited_page", "150": "on_cited_page", "2.4": "on_cited_page" }, "bracket_cites": 0, "text": "Trial regimen: semaglutide subcutaneously once weekly, 0.25, 0.5, 1.0 and 1.7 mg for 4 weeks each, then 2.4 mg for 52 weeks. A 1.7 mg maintenance dose was permitted for intolerance, with an attempt to re-escalate recommended. (CSR pp. 39-40, Tables 9-1 and 9-2.) Both groups received counselling every 4 weeks for a 500 kcal/day deficit and \u2265150 minutes/week of physical activity, with daily food/activity records. (CSR p. 41.)" }, { "id": "1616047389", "alias": "Included studies \u2014 Study 2 intervention regimen", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 5 }, { "id": "1885629606", "alias": "Included studies \u2014 Study 1 comparators", "group": "Included studies", "state": "answered", "chars": 363, "cited_pages": [ 35 ], "sentence_checks": [], "numbers": { "150": "elsewhere", "500": "elsewhere" }, "bracket_cites": 0, "text": "Matching placebo by subcutaneous injection once weekly for 68 weeks, with injection volumes matching the fixed 16-week semaglutide escalation and maintenance regimen; both arms received counselling every 4 weeks for a 500 kcal/day energy deficit and \u2265150 minutes/week of physical activity. Placebo and active product had identical appearance. (CSR pp. 35, 39-42.)" }, { "id": "1684065809", "alias": "Included studies \u2014 Study 2 comparators", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 0 }, { "id": "290423608", "alias": "Included studies \u2014 Study 1 screening duration", "group": "Included studies", "state": "answered", "chars": 52, "cited_pages": [ 35 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "1 week (week \u22121 to week 0). (CSR p. 35, Figure 9-1.)" }, { "id": "442195305", "alias": "Included studies \u2014 Study 2 screening duration", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 17 }, { "id": "1567489723", "alias": "Included studies \u2014 Study 1 run-in duration", "group": "Included studies", "state": "answered", "chars": 52, "cited_pages": [ 35, 36, 37, 38, 39 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "No separate run-in phase described. (CSR pp. 35-39.)" }, { "id": "547609463", "alias": "Included studies \u2014 Study 2 run-in duration", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 4 }, { "id": "1581181457", "alias": "Included studies \u2014 Study 1 treatment duration", "group": "Included studies", "state": "answered", "chars": 64, "cited_pages": [ 35 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "68 weeks: 16-week escalation + 52-week maintenance. (CSR p. 35.)" }, { "id": "1637983798", "alias": "Included studies \u2014 Study 2 treatment duration", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 47 }, { "id": "1316176492", "alias": "Included studies \u2014 Study 1 follow-up duration", "group": "Included studies", "state": "answered", "chars": 69, "cited_pages": [ 35, 36 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "7 weeks off treatment; extension planned separately. (CSR pp. 35-36.)" }, { "id": "155452583", "alias": "Included studies \u2014 Study 2 follow-up duration", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 14 }, { "id": "1244553497", "alias": "Included studies \u2014 Study 1 primary endpoint", "group": "Included studies", "state": "answered", "chars": 79, "cited_pages": [ 59 ], "sentence_checks": [], "numbers": { "5%": "on_cited_page" }, "bracket_cites": 0, "text": "Percentage body-weight change and \u22655% weight loss at week 68. (CSR pp. 59, 87.)" }, { "id": "625389978", "alias": "Included studies \u2014 Study 2 primary endpoint", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 11 }, { "id": "826306291", "alias": "Included studies \u2014 Study 1 secondary endpoints", "group": "Included studies", "state": "answered", "chars": 211, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": { "15%": "on_cited_page", "10%": "on_cited_page" }, "bracket_cites": 0, "text": "Confirmatory: \u226510%/\u226515% weight loss, waist, systolic BP, SF-36 physical functioning and IWQOL-Lite-CT physical function at week 68. Supportive: other weight, metabolic, PRO and safety endpoints. (CSR pp. 59-61.)" }, { "id": "1215263892", "alias": "Included studies \u2014 Study 1 exploratory endpoints", "group": "Included studies", "state": "answered", "chars": 202, "cited_pages": [ 61 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Glycaemic category, antihypertensive/lipid medication use, productivity, permanent treatment discontinuation/time to discontinuation, fatty liver index, urinary incontinence, diet/activity. (CSR p. 61.)" }, { "id": "1730012574", "alias": "Included studies \u2014 Study 2 secondary endpoints", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 22 }, { "id": "606880433", "alias": "Included studies \u2014 Study 2 exploratory endpoints", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 10 }, { "id": "1856749314", "alias": "Included studies \u2014 Study 1 publications", "group": "Included studies", "state": "not_in_csr", "chars": 84, "text": "STEP 1 journal publication not reported. Final CSR dated 17 August 2020. (CSR p. 2.)", "csr_pages_with_field_terms": 0 }, { "id": "563167750", "alias": "Included studies \u2014 Study 1 ClinicalTrials.gov entry", "group": "Included studies", "state": "answered", "chars": 24, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "NCT03548935. (CSR p. 2.)" }, { "id": "815883534", "alias": "Included studies \u2014 Study 2 publications", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 0 }, { "id": "386404186", "alias": "Included studies \u2014 Study 2 ClinicalTrials.gov entry", "group": "Included studies", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 0 }, { "id": "1444027236", "alias": "Long-term extension \u2014 description of studies", "group": "Long-term extension", "state": "answered", "chars": 842, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "1,961": "elsewhere", "4373": "on_cited_page", "1,306": "elsewhere", "2020": "on_cited_page", "129": "on_cited_page", "2018": "on_cited_page", "655": "elsewhere" }, "bracket_cites": 0, "text": "STEP 1 (NN9536-4373; NCT03548935) was a phase 3a, multicentre, multinational, randomized, double-blind, placebo-controlled trial; 1,961 participants were randomized 2:1 (semaglutide 1,306; placebo 655). It included 68 weeks of treatment and 7 weeks of safety follow-up. (CSR pp. 2, 35, 65-66.) It was conducted at 129 sites in 16 countries, including 7 Canadian sites and 63 Canadian participants. Trial initiation was 4 June 2018; primary completion 30 March 2020; completion 19 April 2020. (CSR pp. 2, 69.) The main phase is the included study; extension results are to be reported separately. Data" }, { "id": "1994106587", "alias": "Systematic review \u2014 description of included studies", "group": "Systematic review", "state": "answered", "chars": 842, "cited_pages": [ 2 ], "sentence_checks": [], "numbers": { "1,961": "elsewhere", "4373": "on_cited_page", "1,306": "elsewhere", "2020": "on_cited_page", "129": "on_cited_page", "2018": "on_cited_page", "655": "elsewhere" }, "bracket_cites": 0, "text": "STEP 1 (NN9536-4373; NCT03548935) was a phase 3a, multicentre, multinational, randomized, double-blind, placebo-controlled trial; 1,961 participants were randomized 2:1 (semaglutide 1,306; placebo 655). It included 68 weeks of treatment and 7 weeks of safety follow-up. (CSR pp. 2, 35, 65-66.) It was conducted at 129 sites in 16 countries, including 7 Canadian sites and 63 Canadian participants. Trial initiation was 4 June 2018; primary completion 30 March 2020; completion 19 April 2020. (CSR pp. 2, 69.) The main phase is the included study; extension results are to be reported separately. Data" }, { "id": "827021544", "alias": "Systematic review \u2014 eligibility criteria discussion", "group": "Systematic review", "state": "answered", "chars": 621, "cited_pages": [ 36, 37, 38 ], "sentence_checks": [], "numbers": { "6.5%": "on_cited_page" }, "bracket_cites": 0, "text": "Adults aged \u226518 years with BMI \u226530 kg/m\u00b2, or \u226527 kg/m\u00b2 with hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease, and \u22651 unsuccessful dietary weight-loss effort; type 2 diabetes excluded. (CSR pp. 36-37.) Additional reported exclusions include HbA1c \u22656.5%, >5 kg weight change within 90 days, uncontrolled thyroid disease, PHQ-9 \u226515 at screening and lifetime suicide attempt. Randomization required food-diary completion, PHQ-9 <15 and no specified suicidal behaviour/ideation. The full protocol exclusion list is referenced but not reproduced in the supplied report." }, { "id": "680657803", "alias": "Systematic review \u2014 interventions", "group": "Systematic review", "state": "answered", "chars": 562, "cited_pages": [ 39, 40, 41, 42 ], "sentence_checks": [], "numbers": { "0.25": "on_cited_page", "1.7": "on_cited_page", "500": "on_cited_page", "1.0": "on_cited_page", "0.5": "on_cited_page", "150": "on_cited_page", "2.4": "on_cited_page" }, "bracket_cites": 0, "text": "Trial regimen: semaglutide subcutaneously once weekly, 0.25, 0.5, 1.0 and 1.7 mg for 4 weeks each, then 2.4 mg for 52 weeks. A 1.7 mg maintenance dose was permitted for intolerance, with an attempt to re-escalate recommended. (CSR pp. 39-40, Tables 9-1 and 9-2.) Both groups received counselling every 4 weeks for a 500 kcal/day deficit and \u2265150 minutes/week of physical activity, with daily food/activity records. (CSR p. 41.) Allocation was centralized via IWRS, with subjects, investigators and sponsor blinded; products had identical appearance. (CSR p. 42.)" }, { "id": "1379685635", "alias": "Systematic review \u2014 outcome measures", "group": "Systematic review", "state": "answered", "chars": 1119, "cited_pages": [ 45, 46, 59, 60, 61 ], "sentence_checks": [], "numbers": { "4.3": "elsewhere", "15%": "on_cited_page", "5%": "on_cited_page", "10%": "on_cited_page", "20%": "on_cited_page" }, "bracket_cites": 0, "text": "Co-primary: percentage change in body weight and \u22655% weight loss at week 68. Confirmatory secondary: \u226510% and \u226515% weight loss; changes in waist circumference, systolic blood pressure, SF-36 physical functioning and IWQOL-Lite-CT physical function at week 68. All eight endpoints were in the multiplicity-controlled hierarchy. (CSR pp. 59-61, 87, Tables 9-8 and 11-1.) Supportive/exploratory endpoints included \u226520% weight loss, BMI, lipids, glucose measures, body composition, other quality-of-life scores, medication use, work productivity, urinary incontinence and treatment discontinuation; safet" }, { "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": "7" }, { "id": "1043302581", "alias": "Summary of outcomes \u2014 outcome 1 measure", "group": "Summary of outcomes", "state": "answered", "chars": 57, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": { "5%": "on_cited_page" }, "bracket_cites": 0, "text": "Body-weight change (%) and \u22655% loss* (CSR pp. 59-61, 87.)" }, { "id": "1472210191", "alias": "Summary of outcomes \u2014 outcome 1 timepoint", "group": "Summary of outcomes", "state": "answered", "chars": 28, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Week 68 (CSR pp. 59-61, 87.)" }, { "id": "1842122795", "alias": "Summary of outcomes \u2014 Study 1 outcome 1 classification", "group": "Summary of outcomes", "state": "answered", "chars": 32, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Co-primary* (CSR pp. 59-61, 87.)" }, { "id": "1307588923", "alias": "Summary of outcomes \u2014 Study 2 outcome 1 classification", "group": "Summary of outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 4 }, { "id": "266798436", "alias": "Summary of outcomes \u2014 outcome 2 measure", "group": "Summary of outcomes", "state": "answered", "chars": 70, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": { "15%": "on_cited_page", "10%": "on_cited_page" }, "bracket_cites": 0, "text": "\u226510%/\u226515% loss; waist circumference; systolic BP* (CSR pp. 59-61, 87.)" }, { "id": "1438797414", "alias": "Summary of outcomes \u2014 outcome 2 timepoint", "group": "Summary of outcomes", "state": "answered", "chars": 28, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Week 68 (CSR pp. 59-61, 87.)" }, { "id": "504497766", "alias": "Summary of outcomes \u2014 Study 1 outcome 2 classification", "group": "Summary of outcomes", "state": "answered", "chars": 44, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Confirmatory secondary* (CSR pp. 59-61, 87.)" }, { "id": "1872620584", "alias": "Summary of outcomes \u2014 Study 2 outcome 2 classification", "group": "Summary of outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 4 }, { "id": "24624863", "alias": "Systematic review \u2014 clinical endpoint statistical analysis", "group": "Systematic review", "state": "answered", "chars": 1098, "cited_pages": [ 33, 34, 90, 91, 92, 93, 94, 371 ], "sentence_checks": [], "numbers": { "5%": "on_cited_page", "1,000": "on_cited_page" }, "bracket_cites": 0, "text": "The primary treatment-policy estimand evaluated all randomized participants irrespective of treatment discontinuation or use of other anti-obesity therapy; the secondary hypothetical estimand assumed adherence to randomized therapy without other anti-obesity treatment. (CSR pp. 33-34.) Week-68 percentage body-weight change was analysed by ANCOVA with randomized treatment as factor and baseline body weight as covariate. Binary \u22655% weight-loss response used logistic regression with the same factor and covariate. Missing week-68 outcomes were imputed 1,000 times from retrieved participants in the" }, { "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": "8" }, { "id": "1961702415", "alias": "Statistical analysis \u2014 Study 1 endpoint 1", "group": "Statistical analysis", "state": "answered", "chars": 50, "cited_pages": [ 93 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Body-weight change (%) (CSR pp. 93, 333-334, 346.)" }, { "id": "2143684928", "alias": "Statistical analysis \u2014 Study 1 endpoint 1 model", "group": "Statistical analysis", "state": "answered", "chars": 34, "cited_pages": [ 93 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "ANCOVA (CSR pp. 93, 333-334, 346.)" }, { "id": "1331195698", "alias": "Statistical analysis \u2014 Study 1 endpoint 1 adjustment factors", "group": "Statistical analysis", "state": "answered", "chars": 71, "cited_pages": [ 93 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Treatment factor; baseline weight covariate (CSR pp. 93, 333-334, 346.)" }, { "id": "1125550508", "alias": "Statistical analysis \u2014 Study 1 endpoint 1 missing data", "group": "Statistical analysis", "state": "answered", "chars": 72, "cited_pages": [ 93 ], "sentence_checks": [], "numbers": { "1,000": "on_cited_page" }, "bracket_cites": 0, "text": "Retrieved-dropout multiple imputation \u00d71,000 (CSR pp. 93, 333-334, 346.)" }, { "id": "118805113", "alias": "Statistical analysis \u2014 Study 1 endpoint 1 sensitivity analyses", "group": "Statistical analysis", "state": "answered", "chars": 157, "cited_pages": [ 90, 91, 92 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Jump-to-reference multiple imputation; single imputation S1 and S2 with weight regain; MMRM; two-way tipping-point multiple imputation. (CSR pp. 90-92, 334.)" }, { "id": "932791655", "alias": "Statistical analysis \u2014 Study 1 additional endpoints", "group": "Statistical analysis", "state": "answered", "chars": 200, "cited_pages": [ 59, 60 ], "sentence_checks": [], "numbers": { "15%": "on_cited_page", "10%": "on_cited_page", "5%": "on_cited_page" }, "bracket_cites": 0, "text": "\u22655%, \u226510% and \u226515% body-weight loss at week 68; changes in waist circumference, systolic blood pressure, SF-36 physical functioning and IWQOL-Lite-CT physical function at week 68. (CSR pp. 59-60, 87.)" }, { "id": "724079627", "alias": "Statistical analysis \u2014 Study 1 additional endpoint models", "group": "Statistical analysis", "state": "answered", "chars": 112, "cited_pages": [ 93 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Binary weight-loss responses: logistic regression. Continuous changes: ANCOVA. (CSR pp. 93, 371, 418, 462, 488.)" }, { "id": "1063602554", "alias": "Statistical analysis \u2014 Study 1 additional endpoint adjustment factors", "group": "Statistical analysis", "state": "answered", "chars": 189, "cited_pages": [ 93 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Randomized treatment as factor; baseline body weight as covariate for weight-loss responses, and the corresponding baseline measure for continuous changes. (CSR pp. 93, 371, 418, 462, 488.)" }, { "id": "1996243408", "alias": "Statistical analysis \u2014 Study 1 additional endpoint missing data", "group": "Statistical analysis", "state": "answered", "chars": 147, "cited_pages": [ 93 ], "sentence_checks": [], "numbers": { "1,000": "on_cited_page" }, "bracket_cites": 0, "text": "Missing week-68 outcomes: retrieved-dropout multiple imputation (1,000 imputations) from the same randomized arm. (CSR pp. 93, 371, 418, 462, 488.)" }, { "id": "1507612720", "alias": "Statistical analysis \u2014 Study 1 additional endpoint sensitivity analyses", "group": "Statistical analysis", "state": "answered", "chars": 199, "cited_pages": [ 94 ], "sentence_checks": [], "numbers": { "5%": "on_cited_page" }, "bracket_cites": 0, "text": "For \u22655% response: jump-to-reference, S1, S2, MMRM, non-responder and tipping-point analyses. Waist and physical-function sensitivity analyses are reported separately. (CSR pp. 94, 97, 114, 119, 346.)" }, { "id": "1193492575", "alias": "Statistical analysis \u2014 Study 2 endpoints", "group": "Statistical analysis", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 28 }, { "id": "598107064", "alias": "Statistical analysis \u2014 Study 2 endpoint models", "group": "Statistical analysis", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 23 }, { "id": "1962817948", "alias": "Statistical analysis \u2014 Study 2 endpoint adjustment factors", "group": "Statistical analysis", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 26 }, { "id": "839539422", "alias": "Statistical analysis \u2014 Study 2 endpoint sensitivity analyses", "group": "Statistical analysis", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 44 }, { "id": "1518305444", "alias": "Systematic review \u2014 sample size and power calculation", "group": "Systematic review", "state": "answered", "chars": 420, "cited_pages": [ 36 ], "sentence_checks": [], "numbers": { "99%": "on_cited_page", "650": "on_cited_page", "1,300": "on_cited_page", "1,950": "on_cited_page" }, "bracket_cites": 0, "text": "Planned N=1,950 (1,300 semaglutide; 650 placebo), chosen to support safety exposure/regulatory requirements; reported effective power was 99% for eight hierarchical efficacy endpoints. The IWQOL-Lite-CT power calculation was updated before unblinding without changing sample size. Detailed effect-size/variance assumptions are referenced to the protocol/SAP but not provided in the supplied report. 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SAS: all randomized participants exposed to \u22651 randomized dose, evaluated as treated. DXA: the FAS subset with an acceptable-quality baseline DEXA scan. (CSR p. 58.) FAS and SAS each contained 1,961 participants (semaglutide 1,306; placebo 655); DXA contained 140 (95; 45). A separate per-protocol set is not defined. (CSR pp. 58, 65, 72.) 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(CSR pp. 1, 32.)", "csr_pages_with_field_terms": 40 }, { "id": "161622868", "alias": "Patient disposition \u2014 discontinued from study \u2014 Study 2 treatment 2", "group": "Patient disposition", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 40 }, { "id": "1330433526", "alias": "Patient disposition \u2014 discontinuation due to adverse events \u2014 Study 1 treatment 1", "group": "Patient disposition", "state": "answered", "chars": 98, "cited_pages": [ 136, 137 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "4 consent withdrawals mentioning AEs; not systematically collected. (CSR pp. 136-137, Table 12-7.)" }, { "id": "2137401816", "alias": "Patient disposition \u2014 discontinuation due to adverse events \u2014 Study 1 treatment 2", "group": "Patient disposition", "state": "answered", "chars": 97, "cited_pages": [ 136, 137 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "1 consent withdrawal mentioning AEs; not systematically collected. (CSR pp. 136-137, Table 12-7.)" }, { "id": "767735645", "alias": "Patient disposition \u2014 discontinuation due to adverse events \u2014 Study 2 treatment 1", "group": "Patient disposition", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 89 }, { "id": "432304059", "alias": "Patient disposition \u2014 discontinuation due to adverse events \u2014 Study 2 treatment 2", "group": "Patient disposition", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 89 }, { "id": "1101836181", "alias": "Patient disposition \u2014 discontinuation due to lost to follow-up \u2014 Study 1 treatment 1", "group": "Patient disposition", "state": "answered", "chars": 30, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": { "3.0%": "elsewhere" }, "bracket_cites": 0, "text": "39 (3.0%) (CSR pp. 58, 65-68.)" }, { "id": "1191649653", "alias": "Patient disposition \u2014 discontinuation due to lost to follow-up \u2014 Study 1 treatment 2", "group": "Patient disposition", "state": "answered", "chars": 30, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": { "4.3%": "elsewhere" }, "bracket_cites": 0, "text": "28 (4.3%) (CSR pp. 58, 65-68.)" }, { "id": "1922246875", "alias": "Patient disposition \u2014 discontinuation due to lost to follow-up \u2014 Study 2 treatment 1", "group": "Patient disposition", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 60 }, { "id": "1451180892", "alias": "Patient disposition \u2014 discontinuation due to lost to follow-up \u2014 Study 2 treatment 2", "group": "Patient disposition", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 60 }, { "id": "799002135", "alias": "Patient disposition \u2014 FAS \u2014 Study 1 treatment 1", "group": "Patient disposition", "state": "answered", "chars": 26, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": { "1,306": "elsewhere" }, "bracket_cites": 0, "text": "1,306 (CSR pp. 58, 65-68.)" }, { "id": "1517486783", "alias": "Patient disposition \u2014 FAS \u2014 Study 1 treatment 2", "group": "Patient disposition", "state": "answered", "chars": 24, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": { "655": "elsewhere" }, "bracket_cites": 0, "text": "655 (CSR pp. 58, 65-68.)" }, { "id": "920944957", "alias": "Patient disposition \u2014 FAS \u2014 Study 2 treatment 1", "group": "Patient disposition", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 22 }, { "id": "174187984", "alias": "Patient disposition \u2014 FAS \u2014 Study 2 treatment 2", "group": "Patient disposition", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 22 }, { "id": "1281354242", "alias": "Patient disposition \u2014 PP \u2014 Study 1 treatment 1", "group": "Patient disposition", "state": "answered", "chars": 33, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Not defined. (CSR pp. 58, 65-68.)" }, { "id": "1230215137", "alias": "Patient disposition \u2014 PP \u2014 Study 1 treatment 2", "group": "Patient disposition", "state": "answered", "chars": 33, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Not defined. (CSR pp. 58, 65-68.)" }, { "id": "1682091021", "alias": "Patient disposition \u2014 PP \u2014 Study 2 treatment 1", "group": "Patient disposition", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 22 }, { "id": "380481777", "alias": "Patient disposition \u2014 PP \u2014 Study 2 treatment 2", "group": "Patient disposition", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 22 }, { "id": "621664135", "alias": "Patient disposition \u2014 safety \u2014 Study 1 treatment 1", "group": "Patient disposition", "state": "answered", "chars": 26, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": { "1,306": "elsewhere" }, "bracket_cites": 0, "text": "1,306 (CSR pp. 58, 65-68.)" }, { "id": "344799928", "alias": "Patient disposition \u2014 safety \u2014 Study 1 treatment 2", "group": "Patient disposition", "state": "answered", "chars": 24, "cited_pages": [ 58 ], "sentence_checks": [], "numbers": { "655": "elsewhere" }, "bracket_cites": 0, "text": "655 (CSR pp. 58, 65-68.)" }, { "id": "272364580", "alias": "Patient disposition \u2014 safety \u2014 Study 2 treatment 1", "group": "Patient disposition", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 61 }, { "id": "1044293921", "alias": "Patient disposition \u2014 safety \u2014 Study 2 treatment 2", "group": "Patient disposition", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 61 }, { "id": "379272513", "alias": "Exposure to interventions \u2014 study treatments narrative", "group": "Exposure to interventions", "state": "answered", "chars": 323, "cited_pages": [ 73 ], "sentence_checks": [], "numbers": { "829.6": "elsewhere", "1,706.1": "elsewhere" }, "bracket_cites": 0, "text": "The exposure table uses time to first treatment discontinuation (including temporary interruption), consistent with the CSR narrative. AE summaries use the separate 49-day ascertainment window (1,706.1 versus 829.6 patient-years). These denominators are not interchangeable. (CSR pp. 73, 128, 310; Tables 12-1 and 14.1.23.)" }, { "id": "1129376544", "alias": "Patient exposure table \u2014 number", "group": "Patient exposure table", "state": "answered", "chars": 2, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "12" }, { "id": "999719648", "alias": "Patient exposure \u2014 Study 1 treatment 1", "group": "Patient exposure", "state": "answered", "chars": 31, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "2.4": "on_cited_page" }, "bracket_cites": 0, "text": "Semaglutide 2.4 mg (CSR p. 65.)" }, { "id": "1566511647", "alias": "Patient exposure \u2014 Study 1 treatment 1 sample size", "group": "Patient exposure", "state": "answered", "chars": 18, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "1,306": "on_cited_page" }, "bracket_cites": 0, "text": "1,306 (CSR p. 65.)" }, { "id": "849608264", "alias": "Patient exposure \u2014 Study 1 treatment 2", "group": "Patient exposure", "state": "answered", "chars": 20, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Placebo (CSR p. 65.)" }, { "id": "1311852991", "alias": "Patient exposure \u2014 Study 1 treatment 2 sample size", "group": "Patient exposure", "state": "answered", "chars": 16, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "655": "on_cited_page" }, "bracket_cites": 0, "text": "655 (CSR p. 65.)" }, { "id": "323615679", "alias": "Patient exposure \u2014 Study 2 treatment 1", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 27 }, { "id": "1312152643", "alias": "Patient exposure \u2014 Study 2 treatment 1 sample size", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 32 }, { "id": "1720307850", "alias": "Patient exposure \u2014 Study 2 treatment 2", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 27 }, { "id": "1920971000", "alias": "Patient exposure \u2014 Study 2 treatment 2 sample size", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 32 }, { "id": "1622255754", "alias": "Patient exposure \u2014 total exposure \u2014 Study 1 treatment 1", "group": "Patient exposure", "state": "answered", "chars": 81, "cited_pages": [ 310 ], "sentence_checks": [], "numbers": { "1,480.8": "on_cited_page" }, "bracket_cites": 0, "text": "1,480.8 patient-years (CSR p. 310, Table 14.1.23; time to first discontinuation.)" }, { "id": "1676202065", "alias": "Patient exposure \u2014 total exposure \u2014 Study 1 treatment 2", "group": "Patient exposure", "state": "answered", "chars": 79, "cited_pages": [ 310 ], "sentence_checks": [], "numbers": { "720.9": "on_cited_page" }, "bracket_cites": 0, "text": "720.9 patient-years (CSR p. 310, Table 14.1.23; time to first discontinuation.)" }, { "id": "207093970", "alias": "Patient exposure \u2014 total exposure \u2014 Study 2 treatment 1", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 66 }, { "id": "1600177533", "alias": "Patient exposure \u2014 total exposure \u2014 Study 2 treatment 2", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 66 }, { "id": "586129066", "alias": "Patient exposure \u2014 mean duration \u2014 Study 1 treatment 1", "group": "Patient exposure", "state": "answered", "chars": 77, "cited_pages": [ 310 ], "sentence_checks": [], "numbers": { "59.2": "on_cited_page", "20.2": "on_cited_page" }, "bracket_cites": 0, "text": "59.2 (20.2) weeks (CSR p. 310, Table 14.1.23; time to first discontinuation.)" }, { "id": "604654121", "alias": "Patient exposure \u2014 mean duration \u2014 Study 1 treatment 2", "group": "Patient exposure", "state": "answered", "chars": 77, "cited_pages": [ 310 ], "sentence_checks": [], "numbers": { "20.6": "on_cited_page", "57.4": "on_cited_page" }, "bracket_cites": 0, "text": "57.4 (20.6) weeks (CSR p. 310, Table 14.1.23; time to first discontinuation.)" }, { "id": "748895973", "alias": "Patient exposure \u2014 mean duration \u2014 Study 2 treatment 1", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 81 }, { "id": "782830980", "alias": "Patient exposure \u2014 mean duration \u2014 Study 2 treatment 2", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 81 }, { "id": "1454924577", "alias": "Patient exposure \u2014 median duration \u2014 Study 1 treatment 1", "group": "Patient exposure", "state": "answered", "chars": 81, "cited_pages": [ 310 ], "sentence_checks": [], "numbers": { "73.1": "on_cited_page", "69.1": "on_cited_page", "2.1": "on_cited_page" }, "bracket_cites": 0, "text": "69.1 weeks [2.1-73.1] (CSR p. 310, Table 14.1.23; time to first discontinuation.)" }, { "id": "2045592137", "alias": "Patient exposure \u2014 median duration \u2014 Study 1 treatment 2", "group": "Patient exposure", "state": "answered", "chars": 81, "cited_pages": [ 310 ], "sentence_checks": [], "numbers": { "0.1": "on_cited_page", "69.1": "on_cited_page", "74.7": "on_cited_page" }, "bracket_cites": 0, "text": "69.1 weeks [0.1-74.7] (CSR p. 310, Table 14.1.23; time to first discontinuation.)" }, { "id": "1933422962", "alias": "Patient exposure \u2014 median duration \u2014 Study 2 treatment 1", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 41 }, { "id": "73475143", "alias": "Patient exposure \u2014 median duration \u2014 Study 2 treatment 2", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 41 }, { "id": "768009665", "alias": "Patient exposure \u2014 adherence \u2014 Study 1 treatment 1", "group": "Patient exposure", "state": "not_in_csr", "chars": 95, "text": "Overall adherence % not reported; 89.6% of completers had 2.4 mg at last dose. (CSR pp. 73-74.)", "csr_pages_with_field_terms": 28 }, { "id": "302260809", "alias": "Patient exposure \u2014 adherence \u2014 Study 1 treatment 2", "group": "Patient exposure", "state": "not_in_csr", "chars": 103, "text": "Overall adherence % not reported; 98.0% of completers had matching maintenance volume. (CSR pp. 73-74.)", "csr_pages_with_field_terms": 28 }, { "id": "1662864798", "alias": "Patient exposure \u2014 adherence \u2014 Study 2 treatment 1", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 28 }, { "id": "58236", "alias": "Patient exposure \u2014 adherence \u2014 Study 2 treatment 2", "group": "Patient exposure", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 28 }, { "id": "573479684", "alias": "Concomitant medications and co-interventions \u2014 table and narrative", "group": "Concomitant medications and co-interventions", "state": "answered", "chars": 554, "cited_pages": [ 41, 71, 72 ], "sentence_checks": [], "numbers": { "0.5%": "on_cited_page", "18.5%": "on_cited_page", "13.8%": "on_cited_page", "13.0%": "on_cited_page", "500": "on_cited_page", "26.2%": "on_cited_page", "0.2%": "on_cited_page", "150": "on_cited_page", "1.5%": "on_cited_page", "23.6%": "on_cited_page", "4.6%": "on_cited_page", "0.4%": "on_cited_page" }, "bracket_cites": 0, "text": "Both groups received counselling every 4 weeks for a 500 kcal/day deficit and \u2265150 minutes/week of physical activity, with daily food/activity records. (CSR p. 41.) Baseline concomitant use included renin-angiotensin-system agents (23.6%) and lipid-modifying agents (18.5%) overall. During trial, acid-related-disorder drugs were initiated in 26.2% versus 13.0%, and functional-GI-disorder drugs in 13.8% versus 4.6%. Other anti-obesity medication was used by 5 (0.4%) versus 10 (1.5%), and bariatric surgery by 2 (0.2%) versus 3 (0.5%). (CSR pp. 71-72.)" }, { "id": "2140760690", "alias": "Subsequent treatment \u2014 protocols and treatment summary", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 263, "text": "Other anti-obesity medication during trial: 5 (0.4%) versus 10 (1.5%); bariatric surgery: 2 (0.2%) versus 3 (0.5%). No randomized cross-over is described. Detailed subsequent-therapy regimens and a combined unique-patient total are not reported. (CSR pp. 35, 72.)", "csr_pages_with_field_terms": 130 }, { "id": "1635364622", "alias": "Subsequent treatment \u2014 Study 1 treatment 1", "group": "Subsequent treatment", "state": "answered", "chars": 31, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "2.4": "on_cited_page" }, "bracket_cites": 0, "text": "Semaglutide 2.4 mg (CSR p. 65.)" }, { "id": "1095307890", "alias": "Subsequent treatment \u2014 Study 1 treatment 1 sample size", "group": "Subsequent treatment", "state": "answered", "chars": 18, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "1,306": "on_cited_page" }, "bracket_cites": 0, "text": "1,306 (CSR p. 65.)" }, { "id": "123010935", "alias": "Subsequent treatment \u2014 Study 1 treatment 2", "group": "Subsequent treatment", "state": "answered", "chars": 20, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Placebo (CSR p. 65.)" }, { "id": "636529619", "alias": "Subsequent treatment \u2014 Study 1 treatment 2 sample size", "group": "Subsequent treatment", "state": "answered", "chars": 16, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "655": "on_cited_page" }, "bracket_cites": 0, "text": "655 (CSR p. 65.)" }, { "id": "170657821", "alias": "Subsequent treatment \u2014 Study 2 treatment 1", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 130 }, { "id": "1759837169", "alias": "Subsequent treatment \u2014 Study 2 treatment 1 sample size", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 130 }, { "id": "199072809", "alias": "Subsequent treatment \u2014 Study 2 treatment 2", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 130 }, { "id": "1768588778", "alias": "Subsequent treatment \u2014 Study 2 treatment 2 sample size", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 130 }, { "id": "26345956", "alias": "Subsequent treatment \u2014 received subsequent therapy \u2014 Study 1 treatment 1", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 56, "text": "Combined unique-patient total not reported. (CSR p. 72.)", "csr_pages_with_field_terms": 132 }, { "id": "255594123", "alias": "Subsequent treatment \u2014 received subsequent therapy \u2014 Study 1 treatment 2", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 56, "text": "Combined unique-patient total not reported. (CSR p. 72.)", "csr_pages_with_field_terms": 132 }, { "id": "1512323840", "alias": "Subsequent treatment \u2014 received subsequent therapy \u2014 Study 2 treatment 1", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 132 }, { "id": "1305467402", "alias": "Subsequent treatment \u2014 received subsequent therapy \u2014 Study 2 treatment 2", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 132 }, { "id": "34538665", "alias": "Subsequent treatment \u2014 therapy 1 name", "group": "Subsequent treatment", "state": "answered", "chars": 58, "cited_pages": [ 72 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Other anti-obesity medication (during trial). (CSR p. 72.)" }, { "id": "1588575875", "alias": "Subsequent treatment \u2014 therapy 1 \u2014 Study 1 treatment 1", "group": "Subsequent treatment", "state": "answered", "chars": 22, "cited_pages": [ 72 ], "sentence_checks": [], "numbers": { "0.4%": "on_cited_page" }, "bracket_cites": 0, "text": "5 (0.4%). (CSR p. 72.)" }, { "id": "1693405315", "alias": "Subsequent treatment \u2014 therapy 1 \u2014 Study 1 treatment 2", "group": "Subsequent treatment", "state": "answered", "chars": 23, "cited_pages": [ 72 ], "sentence_checks": [], "numbers": { "1.5%": "on_cited_page" }, "bracket_cites": 0, "text": "10 (1.5%). (CSR p. 72.)" }, { "id": "2051677724", "alias": "Subsequent treatment \u2014 therapy 1 \u2014 Study 2 treatment 1", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 130 }, { "id": "150693318", "alias": "Subsequent treatment \u2014 therapy 1 \u2014 Study 2 treatment 2", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 130 }, { "id": "262182681", "alias": "Subsequent treatment \u2014 therapy 2 name", "group": "Subsequent treatment", "state": "answered", "chars": 46, "cited_pages": [ 72 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Bariatric surgery (during trial). (CSR p. 72.)" }, { "id": "1933197586", "alias": "Subsequent treatment \u2014 therapy 2 \u2014 Study 1 treatment 1", "group": "Subsequent treatment", "state": "answered", "chars": 22, "cited_pages": [ 72 ], "sentence_checks": [], "numbers": { "0.2%": "on_cited_page" }, "bracket_cites": 0, "text": "2 (0.2%). (CSR p. 72.)" }, { "id": "56641577", "alias": "Subsequent treatment \u2014 therapy 2 \u2014 Study 1 treatment 2", "group": "Subsequent treatment", "state": "answered", "chars": 22, "cited_pages": [ 72 ], "sentence_checks": [], "numbers": { "0.5%": "on_cited_page" }, "bracket_cites": 0, "text": "3 (0.5%). (CSR p. 72.)" }, { "id": "44722421", "alias": "Subsequent treatment \u2014 therapy 2 \u2014 Study 2 treatment 1", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 130 }, { "id": "40966385", "alias": "Subsequent treatment \u2014 therapy 2 \u2014 Study 2 treatment 2", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 130 }, { "id": "442796501", "alias": "Systematic review \u2014 efficacy results overview", "group": "Systematic review", "state": "answered", "chars": 524, "cited_pages": [ 2, 87 ], "sentence_checks": [], "numbers": { "0.0001": "elsewhere", "95%": "on_cited_page", "8.88": "on_cited_page", "-14.85%": "elsewhere", "-13.37": "on_cited_page", "11.22": "on_cited_page", "-11.51": "on_cited_page", "2020": "on_cited_page", "-2.41%": "elsewhere", "5%": "on_cited_page", "14.19": "on_cited_page", "-12.44": "on_cited_page", "68,": "on_cited_page" }, "bracket_cites": 0, "text": "Results below distinguish imputed treatment-policy estimates from observed responder proportions. The main data cut-off was 11 May 2020; PK and antibody data cut-off was 1 July 2020. (CSR pp. 2, 58, 87-94.) At week 68, treatment-policy estimated mean body-weight change was \u221214.85% with semaglutide versus \u22122.41% with placebo; difference \u221212.44 percentage points (95% CI \u221213.37 to \u221211.51; p<0.0001). The \u22655% weight-loss odds ratio was 11.22 (95% CI 8.88 to 14.19; p<0.0001). (CSR pp. 87, 89, 93; Tables 11-1 and 11-2.)" }, { "id": "779540617", "alias": "Key efficacy outcomes table \u2014 number", "group": "Key efficacy outcomes table", "state": "answered", "chars": 2, "cited_pages": [], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "14" }, { "id": "970765608", "alias": "Key efficacy outcomes \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "answered", "chars": 31, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "2.4": "on_cited_page" }, "bracket_cites": 0, "text": "Semaglutide 2.4 mg (CSR p. 65.)" }, { "id": "526295874", "alias": "Key efficacy outcomes \u2014 Study 1 treatment 1 sample size", "group": "Key efficacy outcomes", "state": "answered", "chars": 18, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "1,306": "on_cited_page" }, "bracket_cites": 0, "text": "1,306 (CSR p. 65.)" }, { "id": "311876416", "alias": "Key efficacy outcomes \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "answered", "chars": 20, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Placebo (CSR p. 65.)" }, { "id": "2111493099", "alias": "Key efficacy outcomes \u2014 Study 1 treatment 2 sample size", "group": "Key efficacy outcomes", "state": "answered", "chars": 16, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "655": "on_cited_page" }, "bracket_cites": 0, "text": "655 (CSR p. 65.)" }, { "id": "7054391", "alias": "Key efficacy outcomes \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 19 }, { "id": "1549905489", "alias": "Key efficacy outcomes \u2014 Study 2 treatment 1 sample size", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 28 }, { "id": "1694630794", "alias": "Key efficacy outcomes \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 19 }, { "id": "1780355161", "alias": "Key efficacy outcomes \u2014 Study 2 treatment 2 sample size", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 28 }, { "id": "816315485", "alias": "Key efficacy outcomes \u2014 outcome 1 name", "group": "Key efficacy outcomes", "state": "answered", "chars": 47, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Body-weight change (%) at week 68* (CSR p. 87.)" }, { "id": "239039042", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 patients analyzed \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "answered", "chars": 101, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "1,212": "elsewhere", "1,306": "elsewhere" }, "bracket_cites": 0, "text": "FAS 1,306; observed at week 68: 1,212 (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "1557017567", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 patients analyzed \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "answered", "chars": 97, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "577": "elsewhere", "655": "elsewhere" }, "bracket_cites": 0, "text": "FAS 655; observed at week 68: 577 (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "1352217550", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 patients analyzed \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 47 }, { "id": "324590986", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 patients analyzed \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 47 }, { "id": "17731659", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 baseline mean (SD) \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "answered", "chars": 41, "cited_pages": [ 70 ], "sentence_checks": [], "numbers": { "105.4": "on_cited_page", "22.1": "on_cited_page" }, "bracket_cites": 0, "text": "Body weight: 105.4 (22.1) kg (CSR p. 70.)" }, { "id": "667974963", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 baseline mean (SD) \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "answered", "chars": 41, "cited_pages": [ 70 ], "sentence_checks": [], "numbers": { "105.2": "on_cited_page", "21.5": "on_cited_page" }, "bracket_cites": 0, "text": "Body weight: 105.2 (21.5) kg (CSR p. 70.)" }, { "id": "502404951", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 baseline mean (SD) \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 117 }, { "id": "1985777254", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 baseline mean (SD) \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 117 }, { "id": "1130296438", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 change from baseline mean \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 131, "text": "\u221214.85%; arm-specific CI/SE not reported in primary analysis table. (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)", "csr_pages_with_field_terms": 120 }, { "id": "120249606", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 change from baseline mean \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 130, "text": "\u22122.41%; arm-specific CI/SE not reported in primary analysis table. (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)", "csr_pages_with_field_terms": 120 }, { "id": "1348377435", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 change from baseline mean \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 120 }, { "id": "493487227", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 change from baseline mean \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 120 }, { "id": "556859281", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 treatment difference versus control \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "answered", "chars": 114, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "-12.44": "on_cited_page", "-11.51": "on_cited_page", "-13.37": "on_cited_page", "95%": "on_cited_page" }, "bracket_cites": 0, "text": "\u221212.44 percentage points (95% CI \u221213.37 to \u221211.51) (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "219765973", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 treatment difference versus control \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "answered", "chars": 73, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Reference (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "1454700321", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 treatment difference versus control \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 135 }, { "id": "678192564", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 treatment difference versus control \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 135 }, { "id": "36572933", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 P value \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "answered", "chars": 111, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "0.0001": "elsewhere" }, "bracket_cites": 0, "text": "<0.0001; unadjusted p; hierarchy controlled* (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "1404990713", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 P value \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "answered", "chars": 79, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Same comparison (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "2078074349", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 P value \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 52 }, { "id": "594386837", "alias": "Key efficacy outcomes \u2014 Outcome 1 \u2014 P value \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 52 }, { "id": "1409617373", "alias": "Key efficacy outcomes \u2014 outcome 2 name", "group": "Key efficacy outcomes", "state": "answered", "chars": 40, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "5%": "on_cited_page" }, "bracket_cites": 0, "text": "\u22655% weight loss at week 68* (CSR p. 87.)" }, { "id": "114770077", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 n (%) \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "answered", "chars": 93, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "1,212": "elsewhere", "86.4%": "elsewhere", "1,047": "elsewhere" }, "bracket_cites": 0, "text": "1,047/1,212 (86.4%), observed (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "1041734719", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 n (%) \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "answered", "chars": 89, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "577": "elsewhere", "31.5%": "elsewhere", "182": "elsewhere" }, "bracket_cites": 0, "text": "182/577 (31.5%), observed (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "744183689", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 n (%) \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 44 }, { "id": "1985036621", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 n (%) \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 44 }, { "id": "1324230232", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 OR/RR (95% CI) \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "answered", "chars": 119, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "11.22": "on_cited_page", "95%": "on_cited_page", "8.88": "on_cited_page", "14.19": "on_cited_page" }, "bracket_cites": 0, "text": "OR 11.22 (95% CI 8.88-14.19), treatment-policy analysis (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "998044773", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 OR/RR (95% CI) \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "answered", "chars": 73, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Reference (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "247785519", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 OR/RR (95% CI) \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 44 }, { "id": "842433737", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 OR/RR (95% CI) \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 44 }, { "id": "325928357", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 RD (95% CI) \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 113, "text": "RD and 95% CI not reported in CSR analysis table. (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)", "csr_pages_with_field_terms": 44 }, { "id": "647039107", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 RD (95% CI) \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 113, "text": "RD and 95% CI not reported in CSR analysis table. (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)", "csr_pages_with_field_terms": 44 }, { "id": "1510114055", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 RD (95% CI) \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 44 }, { "id": "1583180966", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 RD (95% CI) \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 44 }, { "id": "1550051902", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 P value \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "answered", "chars": 111, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "0.0001": "elsewhere" }, "bracket_cites": 0, "text": "<0.0001; unadjusted p; hierarchy controlled* (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "1795863016", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 P value \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "answered", "chars": 79, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Same comparison (CSR pp. 87, 93, 333, 344; Tables 11-1, 11-2, 14.2.9, 14.2.24.)" }, { "id": "240851443", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 P value \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 52 }, { "id": "370790387", "alias": "Key efficacy outcomes \u2014 Outcome 2 \u2014 P value \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 52 }, { "id": "1622066083", "alias": "Key efficacy outcomes \u2014 outcome 3 name", "group": "Key efficacy outcomes", "state": "answered", "chars": 50, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Survival efficacy: not evaluated. (CSR pp. 59-61.)" }, { "id": "1880703258", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 events n (%) \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 76 }, { "id": "2090084810", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 events n (%) \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 76 }, { "id": "1309615090", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 events n (%) \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 76 }, { "id": "2052284880", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 events n (%) \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 76 }, { "id": "47096707", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 censored n (%) \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 44 }, { "id": "92132039", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 censored n (%) \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 44 }, { "id": "315332718", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 censored n (%) \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 44 }, { "id": "2095235444", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 censored n (%) \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 44 }, { "id": "680809139", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 censoring reason 1 n (%) \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 51 }, { "id": "1557881836", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 censoring reason 1 n (%) \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 51 }, { "id": "558742884", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 censoring reason 1 n (%) \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 51 }, { "id": "2141751981", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 censoring reason 1 n (%) \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 51 }, { "id": "169209948", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 overall survival median (95% CI) \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 58 }, { "id": "1368586605", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 overall survival median (95% CI) \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 58 }, { "id": "2045086494", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 overall survival median (95% CI) \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 58 }, { "id": "1494493718", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 overall survival median (95% CI) \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 58 }, { "id": "944524229", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 HR (95% CI) \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 44 }, { "id": "1620591155", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 HR (95% CI) \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 44 }, { "id": "1811673221", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 HR (95% CI) \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 44 }, { "id": "705423006", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 HR (95% CI) \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 44 }, { "id": "1233171528", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 P value \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 52 }, { "id": "1191145088", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 P value \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 52 }, { "id": "611795967", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 P value \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 52 }, { "id": "1282041341", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 P value \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 52 }, { "id": "1632463656", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 survival probability time point in months", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 14, "text": "Not applicable", "csr_pages_with_field_terms": 31 }, { "id": "1926740996", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 survival probability at reported month \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 77 }, { "id": "1393534921", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 survival probability at reported month \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 77 }, { "id": "187416815", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 survival probability at reported month \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 77 }, { "id": "1760325047", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 survival probability at reported month \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 77 }, { "id": "2072005852", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 difference in survival probability (95% CI) \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 57 }, { "id": "1359029344", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 difference in survival probability (95% CI) \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 57 }, { "id": "1931069503", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 difference in survival probability (95% CI) \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 57 }, { "id": "1602259726", "alias": "Key efficacy outcomes \u2014 Outcome 3 \u2014 difference in survival probability (95% CI) \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 57 }, { "id": "1461528535", "alias": "Key efficacy outcomes \u2014 outcome 4 name", "group": "Key efficacy outcomes", "state": "answered", "chars": 67, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Additional outcomes summarized in text. (CSR pp. 87, 97, 114, 119.)" }, { "id": "1961759050", "alias": "Key efficacy outcomes \u2014 Outcome 4 \u2014 reported result \u2014 Study 1 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 80 }, { "id": "1310400713", "alias": "Key efficacy outcomes \u2014 Outcome 4 \u2014 reported result \u2014 Study 1 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 63, "text": "Not reported; survival efficacy not evaluated. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 80 }, { "id": "1318587757", "alias": "Key efficacy outcomes \u2014 Outcome 4 \u2014 reported result \u2014 Study 2 treatment 1", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 80 }, { "id": "531843204", "alias": "Key efficacy outcomes \u2014 Outcome 4 \u2014 reported result \u2014 Study 2 treatment 2", "group": "Key efficacy outcomes", "state": "not_in_csr", "chars": 43, "text": "Second study not reported. (CSR pp. 1, 32.)", "csr_pages_with_field_terms": 80 }, { "id": "2059624488", "alias": "Systematic review \u2014 efficacy outcome 1 heading", "group": "Systematic review", "state": "answered", "chars": 46, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Body-weight change (%) at week 68 (CSR p. 87.)" }, { "id": "852036331", "alias": "Systematic review \u2014 efficacy outcome 1 narrative", "group": "Systematic review", "state": "answered", "chars": 705, "cited_pages": [ 87, 90, 91, 92 ], "sentence_checks": [], "numbers": { "-11.61": "elsewhere", "-13.37": "on_cited_page", "-12.35": "elsewhere", "68,": "on_cited_page", "-15.29": "on_cited_page", "0.0001": "elsewhere", "-11.04": "elsewhere", "8.88": "on_cited_page", "-11.50": "elsewhere", "-13.70": "elsewhere", "-30%": "on_cited_page", "-2.41%": "elsewhere", "5%": "on_cited_page", "30%": "on_cited_page", "-13.21": "elsewhere", "-11.94": "elsewhere", "-13.55": "on_cited_page", "-14.85%": "elsewhere", "-12.83": "elsewhere", "95%": "on_cited_page", "-12.46": "elsewhere", "-13.32": "elsewhere", "11.22": "on_cited_page", "-11.51": "on_cited_page", "-14.42": "on_cited_page", "14.19": "on_cited_page", "-12.44": "on_cited_page", "-11.96": "elsewhere" }, "bracket_cites": 0, "text": "Body-weight change (%) at week 68. At week 68, treatment-policy estimated mean body-weight change was \u221214.85% with semaglutide versus \u22122.41% with placebo; difference \u221212.44 percentage points (95% CI \u221213.37 to \u221211.51; p<0.0001). The \u22655% weight-loss odds ratio was 11.22 (95% CI 8.88 to 14.19; p<0.0001). (CSR pp. 87, 89, 93; Tables 11-1 and 11-2.) Sensitivity ETDs: jump-to-reference \u221211.94 (95% CI \u221212.83 to \u221211.04); single-imputation S1 \u221212.46 (\u221213.32 to \u221211.61); S2 \u221212.35 (\u221213.21 to \u221211.50); MMRM \u221212.83 (\u221213.70 to \u221211.96), all p<0.0001. No tipping point was reached over tested penalties" }, { "id": "824347249", "alias": "Systematic review \u2014 efficacy endpoint 2 heading", "group": "Systematic review", "state": "answered", "chars": 634, "cited_pages": [ 87, 344 ], "sentence_checks": [], "numbers": { "577": "elsewhere", "10.56": "elsewhere", "11.65": "elsewhere", "15%": "on_cited_page", "12.0%": "on_cited_page", "19.26": "on_cited_page", "15.11": "elsewhere", "20%": "on_cited_page", "1,212": "elsewhere", "0.0001": "elsewhere", "13.14": "elsewhere", "14.68": "on_cited_page", "28.76": "on_cited_page", "1.7%": "on_cited_page", "9.90": "elsewhere", "1,047": "on_cited_page", "4.9%": "on_cited_page", "18.42": "elsewhere", "5%": "on_cited_page", "31.5%": "on_cited_page", "12.10": "elsewhere", "15.48": "elsewhere", "12.89": "on_cited_page", "32.0%": "on_cited_page", "9.68": "elsewhere", "86.4%": "on_cited_page", "388": "on_cited_page", "8.10": "elsewhere", "182": "on_cited_page", "50.5%": "on_cited_page", "69.1%": "on_cited_page", "10.22": "elsewhere", "11.08": "on_cited_page", "8.48": "elsewhere", "95%": "on_cited_page", "12.38": "elsewhere", "14.65": "elsewhere", "838": "on_cited_page", "612": "on_cited_page", "19.44": "on_cited_page", "10%": "on_cited_page" }, "bracket_cites": 0, "text": "Body-weight response at week 68. Observed \u22655% loss: 1,047/1,212 (86.4%) versus 182/577 (31.5%). Sensitivity ORs: jump-to-reference 10.22 (95% CI 8.10-12.89), S1 12.38 (9.90-15.48), S2 12.10 (9.68-15.11), MMRM 14.65 (11.65-18.42) and non-responder imputation 10.56 (8.48-13.14), all p<0.0001. (CSR pp. 344, 346, Tables 14.2.24 and 14.2.27.) For \u226510% loss, observed 838/1,212 (69.1%) versus 69/577 (12.0%); OR 14.68 (11.08-19.44). For \u226515% loss, 612/1,212 (50.5%) versus 28/577 (4.9%); OR 19.26 (12.89-28.76); both p<0.0001 within the hierarchy. \u226520% loss was supportive: 388/1,212 (32.0%) versus" }, { "id": "1204620523", "alias": "Systematic review \u2014 efficacy endpoint 3 heading", "group": "Systematic review", "state": "answered", "chars": 522, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": { "2.42": "on_cited_page", "-10.30": "on_cited_page", "1.80": "on_cited_page", "-8.53": "on_cited_page", "-3.87": "on_cited_page", "0.0001": "elsewhere", "11.35": "on_cited_page", "1.18": "on_cited_page", "-5.10": "on_cited_page", "0.41": "elsewhere", "9.43": "on_cited_page", "7.50": "on_cited_page", "5.25": "elsewhere", "-6.34": "on_cited_page", "-9.42": "on_cited_page", "95%": "on_cited_page", "14.67": "elsewhere", "2.21": "elsewhere", "-4.13": "elsewhere", "-13.54": "elsewhere" }, "bracket_cites": 0, "text": "Other confirmatory outcomes at week 68. Waist change: \u221213.54 versus \u22124.13 cm; difference \u22129.42 (95% CI \u221210.30 to \u22128.53). Systolic BP difference: \u22125.10 mmHg (\u22126.34 to \u22123.87). SF-36 physical functioning change: +2.21 versus +0.41; difference +1.80 (1.18-2.42). IWQOL-Lite-CT physical function change: +14.67 versus +5.25; difference +9.43 (7.50-11.35). All p<0.0001 within the hierarchy. Reported sensitivity analyses supported the conclusions for waist circumference and the two PRO outcomes. (CSR pp. 87, 97, 114, 119.)" }, { "id": "1972125768", "alias": "Efficacy outcome sample \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "answered", "chars": 31, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "2.4": "on_cited_page" }, "bracket_cites": 0, "text": "Semaglutide 2.4 mg (CSR p. 65.)" }, { "id": "937981421", "alias": "Efficacy outcome sample \u2014 treatment 1 sample size", "group": "Efficacy outcome sample", "state": "answered", "chars": 18, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "1,306": "on_cited_page" }, "bracket_cites": 0, "text": "1,306 (CSR p. 65.)" }, { "id": "1258531805", "alias": "Efficacy outcome sample \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "answered", "chars": 20, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Placebo (CSR p. 65.)" }, { "id": "1476786157", "alias": "Efficacy outcome sample \u2014 treatment 2 sample size", "group": "Efficacy outcome sample", "state": "answered", "chars": 16, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "655": "on_cited_page" }, "bracket_cites": 0, "text": "655 (CSR p. 65.)" }, { "id": "1282101737", "alias": "Efficacy outcome sample \u2014 continuous outcome name", "group": "Efficacy outcome sample", "state": "answered", "chars": 53, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Waist circumference (cm), week 68* (CSR pp. 87, 371.)" }, { "id": "1669701757", "alias": "Efficacy outcome sample \u2014 patients analyzed \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "answered", "chars": 54, "cited_pages": [ 371 ], "sentence_checks": [], "numbers": { "1,210": "on_cited_page", "1,306": "on_cited_page" }, "bracket_cites": 0, "text": "FAS 1,306; observed 1,210 (CSR p. 371, Table 14.2.54.)" }, { "id": "228181640", "alias": "Efficacy outcome sample \u2014 patients analyzed \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "answered", "chars": 50, "cited_pages": [ 371 ], "sentence_checks": [], "numbers": { "575": "on_cited_page", "655": "on_cited_page" }, "bracket_cites": 0, "text": "FAS 655; observed 575 (CSR p. 371, Table 14.2.54.)" }, { "id": "609106811", "alias": "Efficacy outcome sample \u2014 baseline mean (SD) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "answered", "chars": 28, "cited_pages": [ 70 ], "sentence_checks": [], "numbers": { "114.6": "on_cited_page", "14.8": "on_cited_page" }, "bracket_cites": 0, "text": "114.6 (14.8) cm (CSR p. 70.)" }, { "id": "1948471711", "alias": "Efficacy outcome sample \u2014 baseline mean (SD) \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "answered", "chars": 28, "cited_pages": [ 70 ], "sentence_checks": [], "numbers": { "114.8": "on_cited_page", "14.4": "on_cited_page" }, "bracket_cites": 0, "text": "114.8 (14.4) cm (CSR p. 70.)" }, { "id": "665321656", "alias": "Efficacy outcome sample \u2014 end-of-treatment value \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 72, "text": "101.13 cm; SE not reported in primary table (CSR p. 371, Table 14.2.54.)", "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": 72, "text": "110.55 cm; SE not reported in primary table (CSR p. 371, Table 14.2.54.)", "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": 72, "text": "\u221213.54 cm; SE not reported in primary table (CSR p. 371, Table 14.2.54.)", "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": 71, "text": "\u22124.13 cm; SE not reported in primary table (CSR p. 371, Table 14.2.54.)", "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": 62, "cited_pages": [ 371 ], "sentence_checks": [], "numbers": { "95%": "on_cited_page", "-10.30": "on_cited_page", "-8.53": "on_cited_page", "-9.42": "on_cited_page" }, "bracket_cites": 0, "text": "\u22129.42 cm (95% CI \u221210.30 to \u22128.53) (CSR p. 371, Table 14.2.54.)" }, { "id": "79267020", "alias": "Efficacy outcome sample \u2014 difference versus control \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "answered", "chars": 38, "cited_pages": [ 371 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Reference (CSR p. 371, Table 14.2.54.)" }, { "id": "296249480", "alias": "Efficacy outcome sample \u2014 P value \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "answered", "chars": 76, "cited_pages": [ 371 ], "sentence_checks": [], "numbers": { "0.0001": "elsewhere" }, "bracket_cites": 0, "text": "<0.0001; unadjusted p, hierarchy controlled* (CSR p. 371, Table 14.2.54.)" }, { "id": "1250120688", "alias": "Efficacy outcome sample \u2014 P value \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "answered", "chars": 44, "cited_pages": [ 371 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Same comparison (CSR p. 371, Table 14.2.54.)" }, { "id": "1413108311", "alias": "Efficacy outcome sample \u2014 dichotomous outcome name", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 62, "text": "Dichotomous outcome: not applicable to waist. (CSR pp. 59-61.)", "csr_pages_with_field_terms": 45 }, { "id": "1314190250", "alias": "Efficacy outcome sample \u2014 n (%) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "csr_pages_with_field_terms": 51 }, { "id": "1137967173", "alias": "Efficacy outcome sample \u2014 n (%) \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "csr_pages_with_field_terms": 51 }, { "id": "215140399", "alias": "Efficacy outcome sample \u2014 OR/RR (95% CI) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "csr_pages_with_field_terms": 51 }, { "id": "709270625", "alias": "Efficacy outcome sample \u2014 OR/RR (95% CI) \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "csr_pages_with_field_terms": 51 }, { "id": "736057284", "alias": "Efficacy outcome sample \u2014 RD (95% CI) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "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": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "csr_pages_with_field_terms": 51 }, { "id": "1615120398", "alias": "Efficacy outcome sample \u2014 P value (dichotomous) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "csr_pages_with_field_terms": 58 }, { "id": "2098439437", "alias": "Efficacy outcome sample \u2014 P value (dichotomous) \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "csr_pages_with_field_terms": 58 }, { "id": "1215509121", "alias": "Efficacy outcome sample \u2014 time-to-event outcome name", "group": "Efficacy outcome sample", "state": "answered", "chars": 49, "cited_pages": [ 59, 60, 61 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Survival outcome: not evaluated. (CSR pp. 59-61.)" }, { "id": "2080988536", "alias": "Efficacy outcome sample \u2014 events n (%) \u2014 treatment 1", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "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": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "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": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "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": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "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": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "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": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "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": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "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": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "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": 60, "text": "Not applicable to waist circumference. (CSR pp. 59-61, 371.)", "csr_pages_with_field_terms": 53 }, { "id": "553107993", "alias": "Efficacy outcome sample \u2014 survival probability at X months \u2014 treatment 2", "group": "Efficacy outcome sample", "state": "not_in_csr", "chars": 60, "text": "Not applicable to waist circumference. 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"Systematic review", "state": "answered", "chars": 16, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "655": "on_cited_page" }, "bracket_cites": 0, "text": "655 (CSR p. 65.)" }, { "id": "1156131808", "alias": "Systematic review \u2014 harms \u2014 \u2265 1 adverse event \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 27, "cited_pages": [ 128 ], "sentence_checks": [], "numbers": { "1,171": "on_cited_page", "89.7%": "on_cited_page" }, "bracket_cites": 0, "text": "1,171 (89.7%) (CSR p. 128.)" }, { "id": "1730456342", "alias": "Systematic review \u2014 harms \u2014 \u2265 1 adverse event \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 25, "cited_pages": [ 128 ], "sentence_checks": [], "numbers": { "86.4%": "on_cited_page", "566": "on_cited_page" }, "bracket_cites": 0, "text": "566 (86.4%) (CSR p. 128.)" }, { "id": "339957549", "alias": "Systematic review \u2014 harms \u2014 adverse event 1 name", "group": "Systematic review", "state": "answered", "chars": 20, "cited_pages": [ 141 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Nausea (CSR p. 141.)" }, { "id": "1676646681", "alias": "Systematic review \u2014 harms \u2014 adverse event 1 \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 33, "cited_pages": [ 141 ], "sentence_checks": [], "numbers": { "577": "on_cited_page", "44.2%": "on_cited_page" }, "bracket_cites": 0, "text": "Nausea: 577 (44.2%) (CSR p. 141.)" }, { "id": "237151303", "alias": "Systematic review \u2014 harms \u2014 adverse event 1 \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 33, "cited_pages": [ 141 ], "sentence_checks": [], "numbers": { "114": "on_cited_page", "17.4%": "on_cited_page" }, "bracket_cites": 0, "text": "Nausea: 114 (17.4%) (CSR p. 141.)" }, { "id": "1494054240", "alias": "Systematic review \u2014 harms \u2014 adverse event 2 name", "group": "Systematic review", "state": "answered", "chars": 23, "cited_pages": [ 141 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Diarrhoea (CSR p. 141.)" }, { "id": "256239603", "alias": "Systematic review \u2014 harms \u2014 adverse event 2 \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 36, "cited_pages": [ 141 ], "sentence_checks": [], "numbers": { "31.5%": "on_cited_page", "412": "on_cited_page" }, "bracket_cites": 0, "text": "Diarrhoea: 412 (31.5%) (CSR p. 141.)" }, { "id": "398526255", "alias": "Systematic review \u2014 harms \u2014 adverse event 2 \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 36, "cited_pages": [ 141 ], "sentence_checks": [], "numbers": { "15.9%": "on_cited_page", "104": "on_cited_page" }, "bracket_cites": 0, "text": "Diarrhoea: 104 (15.9%) (CSR p. 141.)" }, { "id": "476826638", "alias": "Systematic review \u2014 harms \u2014 patients with \u2265 1 SAE \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 24, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": { "9.8%": "on_cited_page", "128": "on_cited_page" }, "bracket_cites": 0, "text": "128 (9.8%) (CSR p. 135.)" }, { "id": "1471880758", "alias": "Systematic review \u2014 harms \u2014 patients with \u2265 1 SAE \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 23, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": { "6.4%": "on_cited_page" }, "bracket_cites": 0, "text": "42 (6.4%) (CSR p. 135.)" }, { "id": "1477737680", "alias": "Systematic review \u2014 harms \u2014 SAE 1 name", "group": "Systematic review", "state": "answered", "chars": 26, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "GI disorders (CSR p. 135.)" }, { "id": "437963654", "alias": "Systematic review \u2014 harms \u2014 SAE 1 \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 27, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": { "1.4%": "on_cited_page" }, "bracket_cites": 0, "text": "GI: 18 (1.4%) (CSR p. 135.)" }, { "id": "705322254", "alias": "Systematic review \u2014 harms \u2014 SAE 1 \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 19, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "GI: 0 (CSR p. 135.)" }, { "id": "1930814023", "alias": "Systematic review \u2014 harms \u2014 SAE 2 name", "group": "Systematic review", "state": "answered", "chars": 37, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Hepatobiliary disorders (CSR p. 135.)" }, { "id": "1406392629", "alias": "Systematic review \u2014 harms \u2014 SAE 2 \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 38, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": { "1.3%": "on_cited_page" }, "bracket_cites": 0, "text": "Hepatobiliary: 17 (1.3%) (CSR p. 135.)" }, { "id": "2006320262", "alias": "Systematic review \u2014 harms \u2014 SAE 2 \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 37, "cited_pages": [ 135 ], "sentence_checks": [], "numbers": { "0.2%": "on_cited_page" }, "bracket_cites": 0, "text": "Hepatobiliary: 1 (0.2%) (CSR p. 135.)" }, { "id": "1483521817", "alias": "Systematic review \u2014 harms \u2014 patients who stopped treatment \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 32, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "7.0%": "on_cited_page" }, "bracket_cites": 0, "text": "92 (7.0%); AE form (CSR p. 137.)" }, { "id": "33425579", "alias": "Systematic review \u2014 harms \u2014 patients who stopped treatment \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 32, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "3.1%": "on_cited_page" }, "bracket_cites": 0, "text": "20 (3.1%); AE form (CSR p. 137.)" }, { "id": "390444819", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 1 name", "group": "Systematic review", "state": "answered", "chars": 26, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "GI disorders (CSR p. 137.)" }, { "id": "360453968", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 1 \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 27, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "4.5%": "on_cited_page" }, "bracket_cites": 0, "text": "GI: 59 (4.5%) (CSR p. 137.)" }, { "id": "488266923", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 1 \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 26, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "0.8%": "on_cited_page" }, "bracket_cites": 0, "text": "GI: 5 (0.8%) (CSR p. 137.)" }, { "id": "80911201", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 2 name", "group": "Systematic review", "state": "answered", "chars": 35, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Psychiatric disorders (CSR p. 137.)" }, { "id": "190329408", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 2 \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 35, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "0.5%": "on_cited_page" }, "bracket_cites": 0, "text": "Psychiatric: 7 (0.5%) (CSR p. 137.)" }, { "id": "1646255212", "alias": "Systematic review \u2014 harms \u2014 stopped-treatment adverse event 2 \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 35, "cited_pages": [ 137 ], "sentence_checks": [], "numbers": { "0.5%": "on_cited_page" }, "bracket_cites": 0, "text": "Psychiatric: 3 (0.5%) (CSR p. 137.)" }, { "id": "721157853", "alias": "Systematic review \u2014 harms \u2014 patients who died \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 32, "cited_pages": [ 128 ], "sentence_checks": [], "numbers": { "0.1%": "on_cited_page" }, "bracket_cites": 0, "text": "1 (0.1%), in-trial (CSR p. 128.)" }, { "id": "1712975059", "alias": "Systematic review \u2014 harms \u2014 patients who died \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 32, "cited_pages": [ 128 ], "sentence_checks": [], "numbers": { "0.2%": "on_cited_page" }, "bracket_cites": 0, "text": "1 (0.2%), in-trial (CSR p. 128.)" }, { "id": "600321283", "alias": "Systematic review \u2014 harms \u2014 causes of death description", "group": "Systematic review", "state": "answered", "chars": 42, "cited_pages": [ 134 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Adjudicated causes of death. (CSR p. 134.)" }, { "id": "77268508", "alias": "Systematic review \u2014 harms \u2014 deaths detail \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 61, "cited_pages": [ 134 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Sudden cardiac death adjudicated; off treatment (CSR p. 134.)" }, { "id": "1083791034", "alias": "Systematic review \u2014 harms \u2014 deaths detail \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 51, "cited_pages": [ 134 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Malignancy adjudicated; off treatment (CSR p. 134.)" }, { "id": "1522498328", "alias": "Systematic review \u2014 harms \u2014 special-interest event name", "group": "Systematic review", "state": "answered", "chars": 62, "cited_pages": [ 129 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "Gallbladder disorders; adjudicated pancreatitis. (CSR p. 129.)" }, { "id": "1533928334", "alias": "Systematic review \u2014 harms \u2014 special-interest event \u2014 treatment 1", "group": "Systematic review", "state": "answered", "chars": 72, "cited_pages": [ 129 ], "sentence_checks": [], "numbers": { "2.6%": "on_cited_page", "0.2%": "on_cited_page" }, "bracket_cites": 0, "text": "Gallbladder: 34 (2.6%); adjudicated pancreatitis: 3 (0.2%) (CSR p. 129.)" }, { "id": "1291278805", "alias": "Systematic review \u2014 harms \u2014 special-interest event \u2014 treatment 2", "group": "Systematic review", "state": "answered", "chars": 64, "cited_pages": [ 129 ], "sentence_checks": [], "numbers": { "1.2%": "on_cited_page" }, "bracket_cites": 0, "text": "Gallbladder: 8 (1.2%); adjudicated pancreatitis: 0 (CSR p. 129.)" }, { "id": "25554223", "alias": "Safety evaluation plan", "group": "Safety evaluation plan", "state": "answered", "chars": 301, "cited_pages": [ 30 ], "sentence_checks": [], "numbers": { "22.1": "elsewhere" }, "bracket_cites": 0, "text": "Safety used the SAS. AEs/SAEs generally used on-treatment exposure with a 49-day window; deaths and selected long-latency events used the in-trial period. Selected events were independently adjudicated, and MedDRA 22.1 was used for coding. Safety was descriptive. (CSR pp. 30, 36, 47-51, 58, 127-129.)" }, { "id": "1037532054", "alias": "Systematic review \u2014 safety evaluation plan", "group": "Systematic review", "state": "answered", "chars": 301, "cited_pages": [ 30 ], "sentence_checks": [], "numbers": { "22.1": "elsewhere" }, "bracket_cites": 0, "text": "Safety used the SAS. AEs/SAEs generally used on-treatment exposure with a 49-day window; deaths and selected long-latency events used the in-trial period. Selected events were independently adjudicated, and MedDRA 22.1 was used for coding. Safety was descriptive. (CSR pp. 30, 36, 47-51, 58, 127-129.)" }, { "id": "298910876", "alias": "Systematic review \u2014 overview of safety", "group": "Systematic review", "state": "answered", "chars": 313, "cited_pages": [ 128 ], "sentence_checks": [], "numbers": { "1,171": "on_cited_page", "128": "on_cited_page", "1,306": "on_cited_page", "7.0%": "on_cited_page", "89.7%": "on_cited_page", "3.1%": "on_cited_page", "86.4%": "on_cited_page", "566": "on_cited_page", "9.8%": "on_cited_page", "6.4%": "on_cited_page", "655": "on_cited_page" }, "bracket_cites": 0, "text": "On-treatment AEs occurred in 1,171/1,306 (89.7%) versus 566/655 (86.4%); SAEs in 128 (9.8%) versus 42 (6.4%); and AEs leading to permanent treatment discontinuation in 92 (7.0%) versus 20 (3.1%), for semaglutide versus placebo. There was 1 death in each group during the in-trial period. (CSR p. 128, Table 12-1.)" }, { "id": "1812042767", "alias": "Overview of safety", "group": "Overview of safety", "state": "answered", "chars": 313, "cited_pages": [ 128 ], "sentence_checks": [], "numbers": { "1,171": "on_cited_page", "128": "on_cited_page", "1,306": "on_cited_page", "7.0%": "on_cited_page", "89.7%": "on_cited_page", "3.1%": "on_cited_page", "86.4%": "on_cited_page", "566": "on_cited_page", "9.8%": "on_cited_page", "6.4%": "on_cited_page", "655": "on_cited_page" }, "bracket_cites": 0, "text": "On-treatment AEs occurred in 1,171/1,306 (89.7%) versus 566/655 (86.4%); SAEs in 128 (9.8%) versus 42 (6.4%); and AEs leading to permanent treatment discontinuation in 92 (7.0%) versus 20 (3.1%), for semaglutide versus placebo. There was 1 death in each group during the in-trial period. (CSR p. 128, Table 12-1.)" }, { "id": "8283627", "alias": "Treatment-emergent adverse events", "group": "Treatment-emergent adverse events", "state": "answered", "chars": 309, "cited_pages": [ 141 ], "sentence_checks": [], "numbers": { "577": "on_cited_page", "15.9%": "on_cited_page", "9.5%": "on_cited_page", "314": "on_cited_page", "23.4%": "on_cited_page", "17.4%": "on_cited_page", "114": "on_cited_page", "47.9%": "on_cited_page", "412": "on_cited_page", "24.8%": "on_cited_page", "969": "on_cited_page", "6.6%": "on_cited_page", "306": "on_cited_page", "31.5%": "on_cited_page", "74.2%": "on_cited_page", "44.2%": "on_cited_page", "324": "on_cited_page", "104": "on_cited_page" }, "bracket_cites": 0, "text": "Gastrointestinal AEs occurred in 969 (74.2%) versus 314 (47.9%); nausea 577 (44.2%) versus 114 (17.4%), diarrhoea 412 (31.5%) versus 104 (15.9%), vomiting 324 (24.8%) versus 43 (6.6%), and constipation 306 (23.4%) versus 62 (9.5%). Most GI events were non-serious and mild/moderate. (CSR p. 141, Table 12-10.)" }, { "id": "680440901", "alias": "Systematic review \u2014 adverse events narrative", "group": "Systematic review", "state": "answered", "chars": 309, "cited_pages": [ 141 ], "sentence_checks": [], "numbers": { "577": "on_cited_page", "15.9%": "on_cited_page", "9.5%": "on_cited_page", "314": "on_cited_page", "23.4%": "on_cited_page", "17.4%": "on_cited_page", "114": "on_cited_page", "47.9%": "on_cited_page", "412": "on_cited_page", "24.8%": "on_cited_page", "969": "on_cited_page", "6.6%": "on_cited_page", "306": "on_cited_page", "31.5%": "on_cited_page", "74.2%": "on_cited_page", "44.2%": "on_cited_page", "324": "on_cited_page", "104": "on_cited_page" }, "bracket_cites": 0, "text": "Gastrointestinal AEs occurred in 969 (74.2%) versus 314 (47.9%); nausea 577 (44.2%) versus 114 (17.4%), diarrhoea 412 (31.5%) versus 104 (15.9%), vomiting 324 (24.8%) versus 43 (6.6%), and constipation 306 (23.4%) versus 62 (9.5%). Most GI events were non-serious and mild/moderate. (CSR p. 141, Table 12-10.)" }, { "id": "1300731115", "alias": "Serious adverse events", "group": "Serious adverse events", "state": "answered", "chars": 250, "cited_pages": [ 134, 135 ], "sentence_checks": [], "numbers": { "128": "on_cited_page", "1.4%": "on_cited_page", "0.2%": "on_cited_page", "9.6": "on_cited_page", "6.4": "on_cited_page", "164": "on_cited_page", "9.8%": "on_cited_page", "1.3%": "on_cited_page", "6.4%": "on_cited_page", "100": "on_cited_page" }, "bracket_cites": 0, "text": "SAEs affected 128 (9.8%) versus 42 (6.4%); 164 versus 53 events, or 9.6 versus 6.4 events per 100 patient-years. Serious GI disorders occurred in 18 (1.4%) versus 0; hepatobiliary disorders in 17 (1.3%) versus 1 (0.2%). (CSR pp. 134-135, Table 12-5.)" }, { "id": "1418799728", "alias": "Systematic review \u2014 serious adverse events narrative", "group": "Systematic review", "state": "answered", "chars": 250, "cited_pages": [ 134, 135 ], "sentence_checks": [], "numbers": { "128": "on_cited_page", "1.4%": "on_cited_page", "0.2%": "on_cited_page", "9.6": "on_cited_page", "6.4": "on_cited_page", "164": "on_cited_page", "9.8%": "on_cited_page", "1.3%": "on_cited_page", "6.4%": "on_cited_page", "100": "on_cited_page" }, "bracket_cites": 0, "text": "SAEs affected 128 (9.8%) versus 42 (6.4%); 164 versus 53 events, or 9.6 versus 6.4 events per 100 patient-years. Serious GI disorders occurred in 18 (1.4%) versus 0; hepatobiliary disorders in 17 (1.3%) versus 1 (0.2%). (CSR pp. 134-135, Table 12-5.)" }, { "id": "1407394812", "alias": "Withdrawls", "group": "Withdrawls", "state": "answered", "chars": 481, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "7.0%": "on_cited_page", "3.2%": "on_cited_page", "3.1%": "on_cited_page" }, "bracket_cites": 0, "text": "AE-form counts for permanent treatment discontinuation were 92 (7.0%) versus 20 (3.1%); end-of-trial-form counts were 91 (7.0%) versus 21 (3.2%). The CSR explicitly explains this one-participant-per-arm discrepancy. Trial withdrawal is separate: Table 12-7 lists 4 semaglutide and 1 placebo participants withdrawing consent with reasons mentioning AEs, plus 1 death per arm; AE-related trial withdrawal was not systematically collected. (CSR pp. 65, 136-137, Tables 12-7 and 12-8.)" }, { "id": "517772690", "alias": "Withdrawals due to adverse events", "group": "Withdrawals due to adverse events", "state": "answered", "chars": 481, "cited_pages": [ 65 ], "sentence_checks": [], "numbers": { "7.0%": "on_cited_page", "3.2%": "on_cited_page", "3.1%": "on_cited_page" }, "bracket_cites": 0, "text": "AE-form counts for permanent treatment discontinuation were 92 (7.0%) versus 20 (3.1%); end-of-trial-form counts were 91 (7.0%) versus 21 (3.2%). The CSR explicitly explains this one-participant-per-arm discrepancy. Trial withdrawal is separate: Table 12-7 lists 4 semaglutide and 1 placebo participants withdrawing consent with reasons mentioning AEs, plus 1 death per arm; AE-related trial withdrawal was not systematically collected. (CSR pp. 65, 136-137, Tables 12-7 and 12-8.)" }, { "id": "1880334514", "alias": "Adverse events of special interest", "group": "Adverse events of special interest", "state": "answered", "chars": 445, "cited_pages": [ 129, 187 ], "sentence_checks": [], "numbers": { "4.26": "on_cited_page", "95%": "on_cited_page", "1.2%": "on_cited_page", "5.15": "on_cited_page", "0.2%": "on_cited_page", "3.38": "on_cited_page", "2.6%": "on_cited_page" }, "bracket_cites": 0, "text": "Safety focus areas included GI and gallbladder disorders, pancreatitis, cardiovascular disorders, neoplasms, hepatic events, renal failure, hypoglycaemia, injection-site/allergic reactions, psychiatric disorders and medication errors. Gallbladder disorders: 34 (2.6%) versus 8 (1.2%); adjudicated pancreatitis: 3 (0.2%) versus 0. (CSR p. 129, Table 12-2.) Pulse-rate difference at week 68 was +4.26 beats/min (95% CI 3.38 to 5.15). (CSR p. 187.)" }, { "id": "951825012", "alias": "Systematic review \u2014 adverse events of special interest", "group": "Systematic review", "state": "answered", "chars": 445, "cited_pages": [ 129, 187 ], "sentence_checks": [], "numbers": { "4.26": "on_cited_page", "95%": "on_cited_page", "1.2%": "on_cited_page", "5.15": "on_cited_page", "0.2%": "on_cited_page", "3.38": "on_cited_page", "2.6%": "on_cited_page" }, "bracket_cites": 0, "text": "Safety focus areas included GI and gallbladder disorders, pancreatitis, cardiovascular disorders, neoplasms, hepatic events, renal failure, hypoglycaemia, injection-site/allergic reactions, psychiatric disorders and medication errors. Gallbladder disorders: 34 (2.6%) versus 8 (1.2%); adjudicated pancreatitis: 3 (0.2%) versus 0. (CSR p. 129, Table 12-2.) Pulse-rate difference at week 68 was +4.26 beats/min (95% CI 3.38 to 5.15). (CSR p. 187.)" }, { "id": "1546147757", "alias": "Systematic review \u2014 sponsor summary and conclusion", "group": "Systematic review", "state": "answered", "chars": 420, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "The sponsor concluded that semaglutide was superior to placebo for both primary and all confirmatory secondary endpoints, with sensitivity analyses supporting robustness. Gastrointestinal adverse effects and treatment discontinuation were more frequent with semaglutide. This describes the CSR conclusion and does not establish reimbursement or comparative efficacy against active treatments. (CSR pp. 87, 128, 188-190.)" }, { "id": "886376493", "alias": "Summary and conclusions", "group": "Summary and conclusions", "state": "answered", "chars": 420, "cited_pages": [ 87 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "The sponsor concluded that semaglutide was superior to placebo for both primary and all confirmatory secondary endpoints, with sensitivity analyses supporting robustness. Gastrointestinal adverse effects and treatment discontinuation were more frequent with semaglutide. This describes the CSR conclusion and does not establish reimbursement or comparative efficacy against active treatments. (CSR pp. 87, 128, 188-190.)" }, { "id": "957324082", "alias": "Systematic review \u2014 sponsor identified gaps", "group": "Systematic review", "state": "not_in_csr", "chars": 303, "text": "The CSR does not provide a CDA-AMC sponsor gap assessment. Source limitations relevant here are a placebo-only comparator, exclusion of type 2 diabetes, 68-week treatment duration, and separately reported extension results. The SF-36 baseline ceiling limited potential improvement. (CSR pp. 35-37, 11", "csr_pages_with_field_terms": 0 }, { "id": "1748456287", "alias": "Gaps in the evidence", "group": "Gaps in the evidence", "state": "not_in_csr", "chars": 303, "text": "The CSR does not provide a CDA-AMC sponsor gap assessment. Source limitations relevant here are a placebo-only comparator, exclusion of type 2 diabetes, 68-week treatment duration, and separately reported extension results. The SF-36 baseline ceiling limited potential improvement. (CSR pp. 35-37, 11", "csr_pages_with_field_terms": null }, { "id": "1100246410", "alias": "Long-term - Description of studies: Study design and objectives", "group": "Long-term", "state": "answered", "chars": 353, "cited_pages": [ 32 ], "sentence_checks": [], "numbers": { "300": "elsewhere" }, "bracket_cites": 0, "text": "Planned 52-week, open-label, off-treatment STEP 1 extension, without structured lifestyle intervention, targeting approximately 300 maintenance-dose completers from Canada, Germany, Japan, UK and US. Objective: assess post-treatment change in weight, cardiovascular risk factors and glucose metabolism. Results are outside this CSR. (CSR pp. 32, 35-36.)" }, { "id": "1563606667", "alias": "Long-term - Description of studies: Eligibility criteria", "group": "Long-term", "state": "not_in_csr", "chars": 234, "text": "Planned subset completing the main phase on semaglutide 2.4 mg or matching placebo maintenance dose, from selected countries; target approximately 300 participants. Detailed extension eligibility is not reported here. (CSR pp. 35-36.)", "csr_pages_with_field_terms": 9 }, { "id": "1790111029", "alias": "Long-term - Description of studies: Intervention", "group": "Long-term", "state": "answered", "chars": 100, "cited_pages": [ 35 ], "sentence_checks": [], "numbers": {}, "bracket_cites": 0, "text": "No trial product and no structured lifestyle intervention during the planned extension. (CSR p. 35.)" }, { "id": "491286797", "alias": "Long-term - Description of studies: Outcomes", "group": "Long-term", "state": "not_in_csr", "chars": 202, "text": "Planned evaluation of body-weight change, cardiovascular risk factors and glucose metabolism after treatment ended; detailed extension endpoint definitions and results are not reported. (CSR pp. 35-36.)", "csr_pages_with_field_terms": 1 }, { "id": "219415411", "alias": "Long-term - Description of studies: Statistical analysis", "group": "Long-term", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 83 }, { "id": "1731720032", "alias": "Long-term extension \u2014 baseline characteristics \u2014 Study 2 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 82 }, { "id": "968217480", "alias": "Long-term extension \u2014 baseline characteristics \u2014 Study 2 treatment 1 sample size", "group": "Long-term extension", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 83 }, { "id": "338135094", "alias": "Long-term extension \u2014 baseline characteristics \u2014 Study 2 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 82 }, { "id": "1318482554", "alias": "Long-term extension \u2014 baseline characteristics \u2014 Study 2 treatment 2 sample size", "group": "Long-term extension", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 83 }, { "id": "1049378464", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 1 name", "group": "Long-term extension", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 12 }, { "id": "256921940", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 1 \u2014 Study 1 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 83 }, { "id": "1496407134", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 1 \u2014 Study 1 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 83 }, { "id": "1836881752", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 1 \u2014 Study 2 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 83 }, { "id": "1176438440", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 1 \u2014 Study 2 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 83 }, { "id": "361470408", "alias": "Long-term extension \u2014 baseline characteristics \u2014 characteristic 3 \u2014 Study 2 treatment 2", "group": "Long-term extension", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 83 }, { "id": "2024381964", "alias": "Patient population: Patient disposition", "group": "Patient population: Patient disposition", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 29 }, { "id": "473484861", "alias": "Long-term - Exposure to study treatments", "group": "Long-term", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "csr_pages_with_field_terms": 1 }, { "id": "1673917880", "alias": "Subsequent treatment", "group": "Subsequent treatment", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 35-36.)", "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": "19" }, { "id": "1253870556", "alias": "Long-term extension \u2014 subsequent treatment \u2014 Study 1 treatment 1", "group": "Long-term extension", "state": "not_in_csr", "chars": 68, "text": "Extension results not reported in supplied CSR. (CSR pp. 32, 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": 68, "text": "Extension results not reported in supplied CSR. 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