{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2950-s1", "verdict_number": "2950", "title": "Lorcaserin × Cardiovascular event superiority (MACE+) — Evidence checklist", "view_version": "1.0", "view_created_date": "2026-10-11", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The preserved whole original verdict summary and selected subclaim were read for production. External abstracts, full text, FDA communications, review papers, registrations, protocols and SAPs were not separately read or accessed. Existing review history is not inherited as clinical verification or a verdict in this production.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Patients with overweight/obesity in the CAMELLIA citation context; exact age, baseline risk and eligibility criteria unverified", "intervention": "Original long-term lorcaserin (Belviq) trial intervention", "dose": "Actual formulation, dose and frequency absent from the original summary and unverified; not medication/usage instructions", "comparator": "Double-blind placebo control; placebo composition and shared care/accompanying treatment unverified", "endpoint": "Cardiovascular efficacy MACE+ superiority; MACE safety noninferiority, weight and cancer harms are separate context", "duration": "CAMELLIA median follow-up 3.3 years; endpoint-specific event windows and individual follow-up durations unverified", "excluded_extensions": [ "Establishing cardiovascular superiority from weight response", "Using MACE noninferiority to resolve MACE+ superiority, cancer or all harms", "Converting nonsignificance to zero effect or equivalence", "Efficacy or safety of other drugs or the class", "Verification of current marketing/authorization status, permission to take the drug or treatment instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Is the selected question cardiovascular event superiority?", "needed": "Links between the selected subclaim, parent and MACE+ results", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: Is the selected question cardiovascular event superiority?", "application_exception": "Do not create new questions, hypothetical main questions or splits.", "criterion": "Preserve exact existing wording and question/verdict records separately.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design / M03 §3.2.4; our own extension boundary", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If the question actually changes, record the original question and excluded scope separately.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The preserved subclaim wording is “Cardiovascular event superiority”. MACE+ efficacy results are linked separately from the parent long-term weight-loss and lorcaserin context.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. The final independent-claim count is not established.", "missingness": "The final count of independent claims remains undetermined.", "uncertainty": "Do not create new questions, hypothetical main questions or splits. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Links between the selected subclaim, parent and MACE+ results" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are subclaim grade D and its note separated from parent grade C and 50 points?", "needed": "Original locations of actual and absent subclaim fields and the parent verdict", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: Are subclaim grade D and its note separated from parent grade C and 50 points?", "application_exception": "Do not fill subclaim-specific values with parent C50/E+/S/I0.", "criterion": "Retain the distinct verdict scope of selected subclaim values and the parent.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design / M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If subclaim fields are actually added, separate the original version and change in a new event.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "Subclaim grade D and “MACE+ was null, HR 0.97, P=0.55” are preserved. Subclaim score, status and axes keys are absent and left null. The parent weight evidence has grade C, 50 points and a safety warning.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. No subclaim-specific score, status or axes are present in the source.", "missingness": "The original record has no subclaim-specific score, status or axes.", "uncertainty": "Do not fill subclaim-specific values with parent C50/E+/S/I0. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original locations of actual and absent subclaim fields and the parent verdict" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are parent axes, cross-checking and the grade decision current verification?", "needed": "Parent Korean and English text, axes, synthesis and verdict/correction history", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: Are parent axes, cross-checking and the grade decision current verification?", "application_exception": "Do not repurpose parent endpoint S or the false large hard-endpoint RCT flag as new classification or review of the selected cardiovascular endpoint.", "criterion": "Preserve original verdict history while leaving current review of the existing content incomplete.", "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design / M08 §8.1–8.2.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "Record subsequent evidence updates as separate events within the user’s requested scope.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The parent’s surrogate endpoint, manufacturer-only evidence, noninferiority design, cross-checking and R1/I0/E+ are existing weight-verdict history. They are not a new clinical review or grade for this cardiovascular sheet.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. No current RoB2 assessment, methodology certification or evidence reassessment was performed.", "missingness": "No current RoB2 assessment, methodology certification or evidence reassessment was performed.", "uncertainty": "Do not repurpose parent endpoint S or the false large hard-endpoint RCT flag as new classification or review of the selected cardiovascular endpoint. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Parent Korean and English text, axes, synthesis and verdict/correction history" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "At what material level did actual reading occur?", "needed": "Acquisition and reading scope for the stored summary and each external material", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: At what material level did actual reading occur?", "application_exception": "Do not convert a URL’s presence to full-text acquisition, link verification or access failure.", "criterion": "Mark local material as summary read and external material as unread.", "basis": "M04 §4.5–4.6 material-collection and selection principles; separation of access and reading and hyperlink rules are our own design / M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If material or reading history is supplied, record the actual reading level of the corresponding slot.", "current_reports": [ "R01", "R02", "R03", "R04", "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The entire designated source summary and selected unit were read for production. External abstracts, full text, FDA communications, registrations and protocols were neither read nor accessed.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. External content is unread, with access not attempted.", "missingness": "External content is unread, with access not attempted.", "uncertainty": "Do not convert a URL’s presence to full-text acquisition, link verification or access failure. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Acquisition and reading scope for the stored summary and each external material" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "How are trials, regulatory reanalysis, reports and weight trials connected?", "needed": "Relationships among citations, registrations, reports, trials and populations", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: How are trials, regulatory reanalysis, reports and weight trials connected?", "application_exception": "Do not add people, cancer events or regulatory documents from the same CAMELLIA trial as new trials or participants.", "criterion": "Distinguish report-entry counts from unestablished unique-trial and population counts.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort and outcome linking is our own application / M04 §4.6.1–4.6.2, M15 §15.3.1; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original lists are supplied, record links between the same family and separate reports.", "current_reports": [ "R01", "R02", "R03", "R04", "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original CAMELLIA trial, FDA cancer reanalysis of the same trial, the paper and communication describing the FDA review, BLOOM and the maintenance trial are distinguished. FDA reanalysis is not a separate efficacy trial.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Unique-trial and participant totals and current independent replication are not established.", "missingness": "Unique-trial and participant totals and current independent replication are not established.", "uncertainty": "Do not add people, cancer events or regulatory documents from the same CAMELLIA trial as new trials or participants. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Relationships among citations, registrations, reports, trials and populations" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Who were the actual CAMELLIA participants?", "needed": "Participant age, diseases/risks, eligibility/exclusion and baseline characteristics", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: Who were the actual CAMELLIA participants?", "application_exception": "Do not certify event effects for all adults or all patients with obesity from a citation title alone.", "criterion": "Retain the original participant wording and gaps in detailed selection conditions.", "basis": "M03 §3.2.1; detailed population conditions are our own design / M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original participant tables are supplied, distinguish the selected population and generalization scope.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The citation title concerns cardiovascular safety in patients with overweight or obesity. The original summary includes 12,000 participants but does not detail age, baseline cardiovascular risk or eligibility/exclusion criteria.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Exact age, baseline risk and eligibility criteria are unverified.", "missingness": "Exact age, baseline risk and eligibility criteria are unverified.", "uncertainty": "Do not certify event effects for all adults or all patients with obesity from a citation title alone. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant age, diseases/risks, eligibility/exclusion and baseline characteristics" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What were the actual lorcaserin formulation, amount and duration of use?", "needed": "Trial formulation, actual intervention amount, frequency, administration/discontinuation and exposure records", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: What were the actual lorcaserin formulation, amount and duration of use?", "application_exception": "Do not create medication instructions or doses absent from the source.", "criterion": "Separate the original intervention name from gaps in actual exposure details.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and assessment adaptations are our own design / M03 §3.2.3, M08 §8.2.2–8.2.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original intervention records are supplied, distinguish nominal and actual exposure and duration.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original context of long-term lorcaserin (Belviq) use and a serotonin 2C receptor agonist for weight loss is preserved. Actual dose, formulation and dosing frequency are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Formulation, dose, frequency and actual adherence/duration of use are unverified.", "missingness": "Formulation, dose, frequency and actual adherence/duration of use are unverified.", "uncertainty": "Do not create medication instructions or doses absent from the source. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial formulation, actual intervention amount, frequency, administration/discontinuation and exposure records" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What were the placebo and accompanying lifestyle care or medications?", "needed": "Placebo characteristics, shared care, accompanying medications and baseline changes", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: What were the placebo and accompanying lifestyle care or medications?", "application_exception": "Do not convert placebo control to a no-care or no-treatment comparison.", "criterion": "Separate the original comparator type from unverified specific comparison conditions.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and assessment adaptations are our own design / M03 §3.2.3, M08 §8.2.2–8.2.3; our own application / M19 §19.2.2–19.2.4 design considerations; detailed confounding records are our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original comparator and accompanying-intervention material is supplied, record actual between-group differences and shared exposure.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "CAMELLIA is preserved as a double-blind, placebo-controlled trial. Placebo formulation, shared lifestyle interventions and the content and balance of accompanying cardiovascular/diabetes treatment are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Placebo composition, accompanying treatment and lifestyle content are unverified.", "missingness": "Placebo composition, accompanying treatment and lifestyle content are unverified.", "uncertainty": "Do not convert placebo control to a no-care or no-treatment comparison. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo characteristics, shared care, accompanying medications and baseline changes" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What were the original randomization size and follow-up duration?", "needed": "Arm-specific allocation, observation, completion and analysis flow and individual follow-up windows", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: What were the original randomization size and follow-up duration?", "application_exception": "Do not make median 3.3-year follow-up the same follow-up time for every participant.", "criterion": "Record allocation denominators and median follow-up separately from actual endpoint-specific denominators.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design / M08 §8.1–8.2.3; Chamgap adaptation / M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original flow/follow-up tables are supplied, record the roles of each denominator and duration.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "CAMELLIA allocated 12,000 participants in groups of 6,000, with median follow-up of 3.3 years. These describe the original allocation size and median follow-up.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Actual endpoint-specific analysis/follow-up denominators and individual follow-up durations are unverified.", "missingness": "Actual endpoint-specific analysis/follow-up denominators and individual follow-up durations are unverified.", "uncertainty": "Do not make median 3.3-year follow-up the same follow-up time for every participant. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific allocation, observation, completion and analysis flow and individual follow-up windows" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What were the components and event definitions of the MACE+ efficacy endpoint?", "needed": "MACE+ components, event adjudication, repeated/first events and endpoint definitions", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: What were the components and event definitions of the MACE+ efficacy endpoint?", "application_exception": "Do not fill in guessed conventional MACE definitions or components from other material.", "criterion": "Preserve the original MACE+ name and leave specific components unverified.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design / M08 Table 8.2.a, M03 §3.2.4; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original plans/result tables are supplied, separate the composite endpoint and each component event.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary labels MACE+ as the primary efficacy endpoint. Individual composite components, first/repeated events and confirmation criteria are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. MACE+ components and adjudication criteria are unverified.", "missingness": "MACE+ components and adjudication criteria are unverified.", "uncertainty": "Do not fill in guessed conventional MACE definitions or components from other material. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "MACE+ components, event adjudication, repeated/first events and endpoint definitions" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What were the original MACE+ event counts, percentages and denominators?", "needed": "People with events/event counts, at-risk population and endpoint analysis denominators", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: What were the original MACE+ event counts, percentages and denominators?", "application_exception": "Do not recalculate original percentages or add the two arms or events together.", "criterion": "Retain original people/percentages and allocation denominators unchanged.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design / M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original event/flow tables are supplied, record whether each value concerns people, repeated events or an analysis denominator.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary records MACE+ in 707 lorcaserin participants (11.8%) versus 727 placebo participants (12.1%). Allocation counts of 6,000/6,000 are preserved separately.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Endpoint-specific analysis denominators, repeated-event handling and at-risk population details are unverified.", "missingness": "Endpoint-specific analysis denominators, repeated-event handling and at-risk population details are unverified.", "uncertainty": "Do not recalculate original percentages or add the two arms or events together. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "People with events/event counts, at-risk population and endpoint analysis denominators" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What were the MACE+ HR, interval and P value?", "needed": "Estimation model, interval confidence level, adjustments and effect of interest", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: What were the MACE+ HR, interval and P value?", "application_exception": "Do not automatically copy the explicit MACE 95% level to the MACE+ interval or calculate new HRs/CIs.", "criterion": "Preserve original MACE+ HR, interval and P value at each originally stated level.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M15 §15.3.1–15.3.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original analysis methods/result tables are supplied, record the definitions of the original HR and interval.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "MACE+ HR 0.97 (0.87~1.07), P=0.55 is preserved. The confidence level of the MACE+ interval is not separately specified in that original summary.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. The MACE+ interval confidence level, model and adjustments were not directly checked.", "missingness": "The MACE+ interval confidence level, model and adjustments were not directly checked.", "uncertainty": "Do not automatically copy the explicit MACE 95% level to the MACE+ interval or calculate new HRs/CIs. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Estimation model, interval confidence level, adjustments and effect of interest" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Does null superiority mean zero effect or equivalence?", "needed": "Prespecified superiority hypothesis, analysis plan and original uncertainty", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: Does null superiority mean zero effect or equivalence?", "application_exception": "Do not convert nonsignificance to zero event difference, equivalence or a personal safety guarantee.", "criterion": "Preserve the original null-result description together with the uncertainty interval.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design / M15 §15.3.1–15.3.3; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original plans are supplied, distinguish the superiority hypothesis from actual estimates and uncertainty.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The subclaim note and parent describe the MACE+ superiority result as null. The original HR 0.97 (0.87~1.07), P=.55 is retained without a new zero-effect or equivalence verdict.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Prespecified superiority-analysis details and the clinical-importance threshold are unverified.", "missingness": "Prespecified superiority-analysis details and the clinical-importance threshold are unverified.", "uncertainty": "Do not convert nonsignificance to zero event difference, equivalence or a personal safety guarantee. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified superiority hypothesis, analysis plan and original uncertainty" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are the MACE cardiovascular safety results preserved separately?", "needed": "MACE definitions, denominators, model and original safety estimates", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: Are the MACE cardiovascular safety results preserved separately?", "application_exception": "Do not repurpose MACE numbers/CIs as MACE+ efficacy results.", "criterion": "Keep original MACE safety values separate from MACE+ efficacy values.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are our own design / M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original safety methods/result tables are supplied, link MACE and MACE+ separately.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary records the MACE safety endpoint in 364 participants (6.1%) versus 369 (6.2%), HR 0.99 (95% CI 0.85~1.14). It is a different endpoint from MACE+ efficacy superiority.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Detailed MACE components, analysis denominators and model are unverified.", "missingness": "Detailed MACE components, analysis denominators and model are unverified.", "uncertainty": "Do not repurpose MACE numbers/CIs as MACE+ efficacy results. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "MACE definitions, denominators, model and original safety estimates" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "To which endpoint does the HR 1.40 noninferiority margin apply?", "needed": "Planned basis for the noninferiority margin, applicable endpoint and analysis population", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: To which endpoint does the HR 1.40 noninferiority margin apply?", "application_exception": "Do not use HR 1.40 as a threshold for MACE+ superiority, cancer safety or overall harmlessness.", "criterion": "Link the original margin, applicable MACE endpoint and unread external plans.", "basis": "M15 §15.3.1–15.3.3; Chamgap adaptation / M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original plans are supplied, distinguish the margin’s definition at the time and the reported results.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary states that the prespecified HR 1.40 margin for MACE cardiovascular safety noninferiority was met. Original registration/plan text remains unread.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. The original planned basis and analysis conditions for the prespecified margin were not directly read.", "missingness": "The original planned basis and analysis conditions for the prespecified margin were not directly read.", "uncertainty": "Do not use HR 1.40 as a threshold for MACE+ superiority, cancer safety or overall harmlessness. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Planned basis for the noninferiority margin, applicable endpoint and analysis population" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are the safety/efficacy endpoint hierarchy and testing order known?", "needed": "Endpoint hierarchy, testing order, multiplicity and change records", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: Are the safety/efficacy endpoint hierarchy and testing order known?", "application_exception": "Do not promote the two primary-endpoint labels to direct certification of all testing procedures.", "criterion": "Distinguish original endpoint roles and unverified hierarchy details.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation / M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If the original SAP/registration is supplied, record the prespecified relationship between safety noninferiority and efficacy superiority.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary explicitly labels MACE as the primary safety endpoint and MACE+ as the primary efficacy endpoint. Hierarchical testing order, alpha allocation and the hierarchy of additional endpoints are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Actual hierarchy, multiplicity and testing order are unverified.", "missingness": "Actual hierarchy, multiplicity and testing order are unverified.", "uncertainty": "Do not promote the two primary-endpoint labels to direct certification of all testing procedures. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint hierarchy, testing order, multiplicity and change records" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are composite and individual cardiovascular events distinguished?", "needed": "Definitions, aggregation, HRs/CIs and prespecified hierarchy of individual component events", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: Are composite and individual cardiovascular events distinguished?", "application_exception": "Do not copy a composite HR as every individual-event HR or mortality benefit.", "criterion": "Retain the boundary between composite endpoints and unverified individual clinical outcomes.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design / M03 §3.2.4; our own extension boundary", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If individual-event tables are supplied, separate direct results for the overall composite and each component.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The MACE and MACE+ composite names and original aggregations are preserved. Effects, denominators and CIs for individual components are absent from the summary.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External material is unread. Direct values for death and individual cardiovascular events and overlap among components are unverified.", "missingness": "Direct values for death and individual cardiovascular events and overlap among components are unverified.", "uncertainty": "Do not copy a composite HR as every individual-event HR or mortality benefit. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Definitions, aggregation, HRs/CIs and prespecified hierarchy of individual component events" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What was the actual cardiovascular analysis observation window?", "needed": "Endpoint-specific start/end times, follow-up after discontinuation and censoring", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: What was the actual cardiovascular analysis observation window?", "application_exception": "Do not replace all event windows with the one-year weight time point or median 3.3 years.", "criterion": "Separate original duration descriptions from endpoint-specific timing gaps.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations by question are our own design / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original follow-up/analysis records are supplied, distinguish median follow-up and actual event windows.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "Median follow-up of 3.3 years is preserved context for CAMELLIA overall. Actual MACE/MACE+ event-aggregation windows, follow-up after discontinuation and censoring times are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Cardiovascular endpoint-specific time definitions and censoring are unverified.", "missingness": "Cardiovascular endpoint-specific time definitions and censoring are unverified.", "uncertainty": "Do not replace all event windows with the one-year weight time point or median 3.3 years. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific start/end times, follow-up after discontinuation and censoring" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What were the HR effect of interest, censoring and competing-risk treatment?", "needed": "Effect of interest, statistical model, censoring/competing events and sensitivity analyses", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: What were the HR effect of interest, censoring and competing-risk treatment?", "application_exception": "Do not interpret an HR as a simple risk ratio or individual prevention probability, or convert it to new values.", "criterion": "Separate original HRs from unverified analysis assumptions.", "basis": "M08 §8.2.2, M15 §15.3.1; our own application / M15 §15.3.1–15.3.3; our own application / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by study design are our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original methods/SAPs are supplied, record the actual estimands and assumptions for each cardiovascular HR.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "Original HRs are supplied, but proportional-hazards assumptions, ITT/actual-use estimands, censoring, competing risks and adjusted models are absent from the summary.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External material is unread. HR models, effects of interest and competing-risk/censoring handling are unverified.", "missingness": "HR models, effects of interest and competing-risk/censoring handling are unverified.", "uncertainty": "Do not interpret an HR as a simple risk ratio or individual prevention probability, or convert it to new values. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Effect of interest, statistical model, censoring/competing events and sensitivity analyses" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What is the scope of blinding and cardiovascular event adjudication?", "needed": "Role-specific blinding, event diagnosis/adjudication and unblinding/detection differences", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: What is the scope of blinding and cardiovascular event adjudication?", "application_exception": "Do not extend a double-blind label to certification of every outcome-adjudication or analysis process.", "criterion": "Separate the original design label from gaps in adjudication details.", "basis": "M08 Table 8.2.a, M03 §3.2.4; our own application / M08 §8.1–8.2.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original adjudication/methods material is supplied, record actual roles and event-collection scope.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary describes CAMELLIA as double-blind and placebo-controlled. Event adjudication committees, data-collection routes and adjudication-blinding details are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Role-specific blinding, independent adjudication and event-confirmation methods are unverified.", "missingness": "Role-specific blinding, independent adjudication and event-confirmation methods are unverified.", "uncertainty": "Do not extend a double-blind label to certification of every outcome-adjudication or analysis process. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Role-specific blinding, event diagnosis/adjudication and unblinding/detection differences" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "What are the details of randomization, concealment and baseline balance?", "needed": "Allocation process, concealment, stratification and baseline-characteristic tables", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: What are the details of randomization, concealment and baseline balance?", "application_exception": "Do not declare all bias conditions satisfied from a randomized label alone.", "criterion": "Keep original allocation labels separate from gaps in direct methods.", "basis": "M08 §8.1–8.2.3; our own application / M03 §3.2.1; detailed population conditions are our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original allocation/baseline material is supplied, distinguish the design description from actual processes.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original scale of 12,000 participants randomized 6,000/6,000 is preserved. Sequence generation, concealment, stratification and baseline-balance details are absent from the summary.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External material is unread. Allocation processes, concealment and baseline balance are unverified.", "missingness": "Allocation processes, concealment and baseline balance are unverified.", "uncertainty": "Do not declare all bias conditions satisfied from a randomized label alone. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation process, concealment, stratification and baseline-characteristic tables" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "How were CAMELLIA attrition, missing data and treatment crossover handled?", "needed": "Arm-specific flow, discontinuation/crossover, missing-data reasons, ITT/PP and sensitivity analyses", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: How were CAMELLIA attrition, missing data and treatment crossover handled?", "application_exception": "Do not transfer BLOOM retention as CAMELLIA follow-up/analysis percentages.", "criterion": "Do not mix denominators and missing-data material across trials.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design / M08 §8.2.2, M15 §15.3.1; our own application / M19 §19.1.2–19.2.4, M04 §4.6.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original flow/analysis material is supplied, distinguish allocation, use, measurement and analysis denominators.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "CAMELLIA allocation size and median follow-up are available, but arm-specific attrition, treatment discontinuation, crossover, missing data and analysis-population details are absent from the summary.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External material is unread. CAMELLIA endpoint-specific missing-data/attrition and ITT/PP handling details are unverified.", "missingness": "CAMELLIA endpoint-specific missing-data/attrition and ITT/PP handling details are unverified.", "uncertainty": "Do not transfer BLOOM retention as CAMELLIA follow-up/analysis percentages. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific flow, discontinuation/crossover, missing-data reasons, ITT/PP and sensitivity analyses" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are people, composite events and repeated measurements different units?", "needed": "Aggregation rules for people/events/first/repeated events, time points and overlapping outcomes", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: Are people, composite events and repeated measurements different units?", "application_exception": "Do not add counts from different endpoints/time points as independent populations or total events.", "criterion": "Retain original units and do not create unestablished totals.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design / M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original aggregation tables are supplied, record each unit and reporting relationship.", "current_reports": [ "R01", "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "Original MACE/MACE+ descriptions use people and percentages; cancer diagnoses, primary-cancer counts and weight responses use other outcome units. Events and time points from the same participants are not counted as new participants.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Event overlap, repeated-event handling and exact endpoint-specific at-risk populations are unverified.", "missingness": "Event overlap, repeated-event handling and exact endpoint-specific at-risk populations are unverified.", "uncertainty": "Do not add counts from different endpoints/time points as independent populations or total events. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Aggregation rules for people/events/first/repeated events, time points and overlapping outcomes" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Were the NCT and prespecified plans actually compared?", "needed": "Preregistration timing, endpoints/hierarchy, plan changes and analysis documents", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: Were the NCT and prespecified plans actually compared?", "application_exception": "Do not count the same NCT as two independent-trial registrations or convert it to certification of prespecification.", "criterion": "Distinguish original registration strings and the scope of unread external material.", "basis": "M04 §4.5–4.6 provide collection and selection principles; separating access from reading and the hyperlink convention are our own design / M08 Table 8.2.a, M04 §4.6.3; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original registration/plan material is supplied, link actual timing and prespecified definitions.", "current_reports": [ "R01", "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original CAMELLIA trial and FDA reanalysis share NCT02019264. The registration identifier is preserved, but registration, protocol and SAP originals remain unread.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Direct content and timing of preregistration/plans are unverified.", "missingness": "Direct content and timing of preregistration/plans are unverified.", "uncertainty": "Do not count the same NCT as two independent-trial registrations or convert it to certification of prespecification. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Preregistration timing, endpoints/hierarchy, plan changes and analysis documents" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are subgroup- and duration-specific cardiovascular effects known?", "needed": "Prespecified subgroup hypotheses, interactions and arm-specific denominators/HRs/intervals", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: Are subgroup- and duration-specific cardiovascular effects known?", "application_exception": "Do not copy the overall HR as an effect for specific populations, durations or optimal exposure.", "criterion": "Retain gaps in direct evidence outside the overall results.", "basis": "M03 §3.2.1; detailed population conditions are our own design / M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If subgroup analyses are supplied, separate overall comparisons and subgroup interactions.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary contains overall MACE/MACE+ values. It lacks effect-modification results by risk, sex, comorbidities, actual exposure amount or duration.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External material is unread. Direct subgroup/duration-specific estimates and interactions are unverified.", "missingness": "Direct subgroup/duration-specific estimates and interactions are unverified.", "uncertainty": "Do not copy the overall HR as an effect for specific populations, durations or optimal exposure. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified subgroup hypotheses, interactions and arm-specific denominators/HRs/intervals" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are superiority’s clinical importance and interpretation of all outcomes the same?", "needed": "Prespecified efficacy-importance criteria, absolute outcomes and individual components/quality of life", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: Are superiority’s clinical importance and interpretation of all outcomes the same?", "application_exception": "Do not use the MACE noninferiority HR 1.40 as an efficacy-importance threshold.", "criterion": "Retain the original superiority result’s scope without thresholds from other endpoints.", "basis": "M15 §15.3.1–15.3.3; our own application / M03 §3.2.4; our own boundary on extensions", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original importance/outcome material is supplied, record statistical estimates and criteria for clinical scope separately.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original MACE+ interval and P=.55 are preserved. The superiority result is not extended to guaranteed cardiovascular-event improvement, equivalence or a single conclusion about all benefits/risks.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Prespecified MACE+ clinical-importance criteria and direct absolute effects/intervals are unverified.", "missingness": "Prespecified MACE+ clinical-importance criteria and direct absolute effects/intervals are unverified.", "uncertainty": "Do not use the MACE noninferiority HR 1.40 as an efficacy-importance threshold. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified efficacy-importance criteria, absolute outcomes and individual components/quality of life" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Is the CAMELLIA one-year weight response an event effect?", "needed": "Boundaries between weight-response definitions, denominators/time points and direct event results", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: Is the CAMELLIA one-year weight response an event effect?", "application_exception": "Do not transfer positive weight response as MACE+ superiority or a selected subclaim score.", "criterion": "Preserve sibling context without adding it as new questions or trials.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design / M03 §3.2.4; Chamgap extension boundary / M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original results are added, record weight and direct cardiovascular outcomes separately.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "CAMELLIA at least 5% weight loss at one year was 38.7% versus 17.4%, P<0.001. The sibling response sheet preserves this response, a different question from the selected cardiovascular event superiority.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Actual endpoint-specific analysis denominators and intervals for weight response are unverified.", "missingness": "Actual endpoint-specific analysis denominators and intervals for weight response are unverified.", "uncertainty": "Do not transfer positive weight response as MACE+ superiority or a selected subclaim score. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Boundaries between weight-response definitions, denominators/time points and direct event results" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are BLOOM weight response and retention separate context?", "needed": "BLOOM actual analysis denominators, missing data/retention and registration information", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: Are BLOOM weight response and retention separate context?", "application_exception": "Do not repurpose BLOOM weight/retention values as CAMELLIA events or attrition.", "criterion": "Retain the boundary between a separate weight trial and selected cardiovascular results.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation / M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design / M03 §3.2.4; Chamgap extension boundary", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original BLOOM material is supplied, link weight results and denominators/retention only to that trial.", "current_reports": [ "R03" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "BLOOM randomized 3,182 participants; at least 5% loss at 52 weeks was 47.5% versus 20.3%, with one-year retention of 55.4% (883/1595) versus 45.1% (716/1587). This is original weight context.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. The original BLOOM registration field is not applicable; actual registration information and cardiovascular superiority material are unverified.", "missingness": "The original BLOOM registration field is not applicable; actual registration information and cardiovascular superiority material are unverified.", "uncertainty": "Do not repurpose BLOOM weight/retention values as CAMELLIA events or attrition. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "BLOOM actual analysis denominators, missing data/retention and registration information" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What were the maintenance trial’s 24-week and 52-week results?", "needed": "Time-specific/co-primary outcome denominators, definitions, intervals, meaning of ± and registration/analysis plans", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: What were the maintenance trial’s 24-week and 52-week results?", "application_exception": "Do not transfer a 24-week signal as 52-week weight maintenance or CAMELLIA cardiovascular events.", "criterion": "Preserve original maintenance results and time-specific gaps separately.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design / M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design / M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation / M03 §3.2.4; Chamgap extension boundary", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original maintenance material is supplied, record time points, co-primary endpoints, denominators and uncertainty.", "current_reports": [ "R04" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The maintenance trial concerns 137 participants who lost at least 5% with a low-calorie diet. At 24 weeks, at least 5% maintenance was 73.9% versus 57.4% (P=.033), with additional −2.4±0.8 kg versus +0.6±0.8 kg (P=.010); neither 52-week co-primary result showed a between-group difference.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Quantitative 52-week effects/intervals, each analysis denominator, the meaning of ± and actual registration information are unverified.", "missingness": "Quantitative 52-week effects/intervals, each analysis denominator, the meaning of ± and actual registration information are unverified.", "uncertainty": "Do not transfer a 24-week signal as 52-week weight maintenance or CAMELLIA cardiovascular events. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Time-specific/co-primary outcome denominators, definitions, intervals, meaning of ± and registration/analysis plans" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What is the extension scope from weight/maintenance to long-term clinical events?", "needed": "Actual duration-specific clinical outcomes, weight maintenance and follow-up after discontinuation", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: What is the extension scope from weight/maintenance to long-term clinical events?", "application_exception": "Do not automatically extend weight loss to improved long-term events, mortality or quality of life.", "criterion": "Preserve the different outcomes of weight signals and direct cardiovascular events.", "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap design / M03 §3.2.4; Chamgap extension boundary", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If direct long-term results are supplied, separate trials/time points and surrogates/clinical events.", "current_reports": [ "R01", "R03", "R04" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The parent describes weight as a surrogate for clinical events and maintenance results as inconsistent. Cardiovascular superiority is a separate direct MACE+ result.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Long-term clinical benefit and effects after discontinuation that cannot be explained by weight results are unverified.", "missingness": "Long-term clinical benefit and effects after discontinuation that cannot be explained by weight results are unverified.", "uncertainty": "Do not automatically extend weight loss to improved long-term events, mortality or quality of life. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual duration-specific clinical outcomes, weight maintenance and follow-up after discontinuation" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What is the original history of the developer program and independent replication?", "needed": "Original lists of report/developer/author/funding relationships and independent material", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: What is the original history of the developer program and independent replication?", "application_exception": "Do not calculate independent-replication counts from separate trial/citation counts or regulatory reviews.", "criterion": "Preserve original nonindependent-program history without new independence certification.", "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation / Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items / M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If relevant material is supplied, distinguish clinical-trial families from funding/author independence.", "current_reports": [ "R01", "R03" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary states that BLOOM and CAMELLIA share a developer program with overlapping funding and authors, are not independent replication by different research teams/funders, and retain R1.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Current unique-trial counts and exhaustive lists of independent families are not established.", "missingness": "Current unique-trial counts and exhaustive lists of independent families are not established.", "uncertainty": "Do not calculate independent-replication counts from separate trial/citation counts or regulatory reviews. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original lists of report/developer/author/funding relationships and independent material" }, { "item_id": "N32", "question_type": "Harm and regulatory scope", "question": "In which material context do the original FDA cancer-reanalysis results belong?", "needed": "Original FDA communications/review material, cancer definitions, collection/adjudication and event-specific results", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: In which material context do the original FDA cancer-reanalysis results belong?", "application_exception": "Do not turn regulatory reanalysis into a separate efficacy trial, new participants or directly read paper results.", "criterion": "Preserve the original FDA summary as regulatory/safety context.", "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design / M19 §19.1.2–19.2.4; Chamgap adaptation / M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original regulatory material is supplied, record the decision at the time, clinical aggregation and direct content separately.", "current_reports": [ "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary’s FDA reanalysis of completed data describes 462 people diagnosed with cancer (7.7%, 520 primary cancers) versus 423 (7.1%, 470 cancers), with pancreatic, colorectal and lung cancer imbalances contributing. It concerns safety in the same CAMELLIA trial.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Original regulatory material and cancer-collection/adjudication details remain unread.", "missingness": "Original regulatory material and cancer-collection/adjudication details remain unread.", "uncertainty": "Do not turn regulatory reanalysis into a separate efficacy trial, new participants or directly read paper results. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original FDA communications/review material, cancer definitions, collection/adjudication and event-specific results" }, { "item_id": "N33", "question_type": "Harm and regulatory scope", "question": "Are people diagnosed with cancer and primary-cancer counts distinguished?", "needed": "People/primary cancers/overlap/duration and at-risk population denominators", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: Are people diagnosed with cancer and primary-cancer counts distinguished?", "application_exception": "Do not add people with cancer and cancer counts or back-calculate duplicate people.", "criterion": "Keep original people, counts and percentages separated and unchanged.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design / M19 §19.1.2–19.2.4; Chamgap adaptation / M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original cancer-aggregation tables are supplied, link units and observation periods for people and multiple primary cancers.", "current_reports": [ "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "Cancer diagnoses involved 462 versus 423 people, while primary-cancer counts were 520 versus 470: different units. The context is the same 12,000-participant CAMELLIA trial.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Multiple-primary-cancer handling, follow-up/analysis denominators and cancer-type-specific values are unverified.", "missingness": "Multiple-primary-cancer handling, follow-up/analysis denominators and cancer-type-specific values are unverified.", "uncertainty": "Do not add people with cancer and cancer counts or back-calculate duplicate people. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "People/primary cancers/overlap/duration and at-risk population denominators" }, { "item_id": "N34", "question_type": "Harm and regulatory scope", "question": "Is one additional cancer per 470 patient-years the original estimate?", "needed": "Patient-year estimation method, observation windows and time-specific cancer/exposure denominators", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: Is one additional cancer per 470 patient-years the original estimate?", "application_exception": "Do not convert the original 470 patient-years value to individual risk, a new NNH or back-calculated events.", "criterion": "Retain time/units and estimation limitations in the original regulatory summary.", "basis": "M19 §19.2 design-specific harm questions; temporal-relationship details are Chamgap design / M19 §19.1.2–19.2.4; Chamgap adaptation / M19 §19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original time/analysis material is supplied, record the estimate’s observation scope and denominator.", "current_reports": [ "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original FDA summary of approximately one additional cancer per 470 patient-years of treatment and a widening difference over time is preserved.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Original estimation methods, time-specific tables and cumulative-exposure denominators are unverified.", "missingness": "Original estimation methods, time-specific tables and cumulative-exposure denominators are unverified.", "uncertainty": "Do not convert the original 470 patient-years value to individual risk, a new NNH or back-calculated events. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Patient-year estimation method, observation windows and time-specific cancer/exposure denominators" }, { "item_id": "N35", "question_type": "Harm and regulatory scope", "question": "Are regulatory cancer decisions and statistical confirmation distinguished?", "needed": "Original overall-cancer estimates/intervals, basis for regulatory decisions and prespecified thresholds", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: Are regulatory cancer decisions and statistical confirmation distinguished?", "application_exception": "Do not calculate or invent new cancer HRs/CIs/P values, statistical significance or causal certification.", "criterion": "Distinguish original regulatory judgments from gaps in direct statistical material.", "basis": "Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool / M19 §19.1.2–19.2.4; Chamgap adaptation / M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original statistical/regulatory material is supplied, record original decisions, estimates and uncertainty separately.", "current_reports": [ "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary explicitly states that the public FDA safety communication lacked overall-cancer HR, CI and P values, and distinguishes regulatory judgment from statistically confirmed overall-cancer harm.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Direct material on overall-cancer HR, CI, P values and prespecified clinical thresholds remains unread.", "missingness": "Direct material on overall-cancer HR, CI, P values and prespecified clinical thresholds remains unread.", "uncertainty": "Do not calculate or invent new cancer HRs/CIs/P values, statistical significance or causal certification. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original overall-cancer estimates/intervals, basis for regulatory decisions and prespecified thresholds" }, { "item_id": "N36", "question_type": "Harm and regulatory scope", "question": "What are the original date and scope of the market-withdrawal record?", "needed": "Original FDA communication, withdrawal date/region and separate update scope for current product status", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: What are the original date and scope of the market-withdrawal record?", "application_exception": "Do not promote original historical status to a completed current authorization/marketing lookup.", "criterion": "Retain original dates and US withdrawal alongside the scope not currently looked up.", "basis": "M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design / Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If actual status material is supplied, record withdrawal at the time and verification of current status as separate events.", "current_reports": [ "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary records the FDA request for voluntary withdrawal on February 13, 2020 and Eisai’s US market withdrawal in 2020. “No longer marketed” is also original wording from the existing reference date.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Current marketing/authorization status was not externally looked up in this production.", "missingness": "Current marketing/authorization status was not externally looked up in this production.", "uncertainty": "Do not promote original historical status to a completed current authorization/marketing lookup. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original FDA communication, withdrawal date/region and separate update scope for current product status" }, { "item_id": "N37", "question_type": "Harm and regulatory scope", "question": "Does cardiovascular noninferiority substitute for cancer or overall safety?", "needed": "Endpoint-specific safety results, harm collection and scope of decisions", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: Does cardiovascular noninferiority substitute for cancer or overall safety?", "application_exception": "Do not convert meeting MACE noninferiority to absence of all harms or permission to take the drug.", "criterion": "Separate endpoint-specific safety scope and other long-term harms.", "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation / Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool / M19 §19.1.2–19.2.4; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If harm material is supplied, record cardiovascular safety, cancer signals and other harms as separate endpoints.", "current_reports": [ "R01", "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original counterview explicitly states that cardiovascular noninferiority does not substitute for cancer safety. The parent safety warning is preserved as original history.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Details of all harms and other safety endpoints are unverified.", "missingness": "Details of all harms and other safety endpoints are unverified.", "uncertainty": "Do not convert meeting MACE noninferiority to absence of all harms or permission to take the drug. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific safety results, harm collection and scope of decisions" }, { "item_id": "N38", "question_type": "Harm and regulatory scope", "question": "Are harm collection, discontinuation and missing follow-up verified?", "needed": "All-harm collection, event definitions, discontinuation, attrition/missing data and follow-up", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: Are harm collection, discontinuation and missing follow-up verified?", "application_exception": "Do not label a safety summary’s presence as complete collection of all harms or zero events.", "criterion": "Distinguish currently unread material from confirmation that original results were unreported.", "basis": "M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design / M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation / M08 §8.2.2, M15 §15.3.1; Chamgap adaptation", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original safety flow/tables are supplied, distinguish event collection, unreported results and unread material.", "current_reports": [ "R01", "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "Cancer reanalysis and a safety warning appear in the original summary, but there are no arm-specific tables of systematic/spontaneous harm collection, severity or discontinuation/attrition.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External material is unread. Harm-collection methods, discontinuation/missing data and disclosure scope for all events are unverified.", "missingness": "Harm-collection methods, discontinuation/missing data and disclosure scope for all events are unverified.", "uncertainty": "Do not label a safety summary’s presence as complete collection of all harms or zero events. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "All-harm collection, event definitions, discontinuation, attrition/missing data and follow-up" }, { "item_id": "N39", "question_type": "Harm and regulatory scope", "question": "What are alternative harm causes and long-term/rare harms or vulnerable populations?", "needed": "Baseline/concurrent risks, exposure/follow-up, population-specific harms and alternative explanations", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: What are alternative harm causes and long-term/rare harms or vulnerable populations?", "application_exception": "Do not establish a regulatory signal as causality or risk magnitude for all participants, exposures or the class.", "criterion": "Distinguish original signals from unverified alternatives or extension scope.", "basis": "M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design / M19 §19.1.2–19.2.4; Chamgap adaptation / M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original long-term/population-specific material is supplied, distinguish original observations from gaps for other populations and rare harms.", "current_reports": [ "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original summary includes cancer imbalance over time, but lacks direct analyses of baseline cancer risk, concurrent treatment and particular populations or rare harms.", "condition_status": "Unverified", "status_reason": "Required direct details are absent from the stored summary and remain unverified. External material is unread. Direct material on alternative causes, subgroups, rare harms and other long-term harms is unverified.", "missingness": "Direct material on alternative causes, subgroups, rare harms and other long-term harms is unverified.", "uncertainty": "Do not establish a regulatory signal as causality or risk magnitude for all participants, exposures or the class. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline/concurrent risks, exposure/follow-up, population-specific harms and alternative explanations" }, { "item_id": "N40", "question_type": "Harm and regulatory scope", "question": "Are harm records from regulatory reanalysis, a paper and a communication independent replication?", "needed": "Aggregation relationships among original material/re-citations, reviews, communications and papers", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: Are harm records from regulatory reanalysis, a paper and a communication independent replication?", "application_exception": "Do not count three documents, the same registration and the same cancer records as three independent populations.", "criterion": "Preserve relationships between document slots and the original population.", "basis": "M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap designs / M04 §4.6.1–4.6.2 on distinguishing studies from reports; cohort and outcome connections are Chamgap adaptations", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If relevant original documents are supplied, record identity and event relationships between reanalysis and independent material.", "current_reports": [ "R01", "R02", "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original trial and FDA reanalysis concern the same CAMELLIA population; the related review paper and communication also refer to that trial. They are not added as new independent harm trials.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Independent harm replication and aggregation of new unique events are not established.", "missingness": "Independent harm replication and aggregation of new unique events are not established.", "uncertainty": "Do not count three documents, the same registration and the same cancer records as three independent populations. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Aggregation relationships among original material/re-citations, reviews, communications and papers" }, { "item_id": "N41", "question_type": "Evidence condition", "question": "At what level are each report’s funding, author and operational roles recorded?", "needed": "Original report-specific funding, product provision, analysis/reporting, author affiliations and COI disclosures", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: At what level are each report’s funding, author and operational roles recorded?", "application_exception": "Do not convert “reported in the original text” to full-text reading in this production or establishment of a specific sponsor.", "criterion": "Retain original report-specific roles/funding descriptions and gaps separately.", "basis": "CHAMGAP's own independence and attribution conditions. Official methodological sections used in this pilot do not guarantee every detail of this item / M04 §4.6.1–4.6.2, M15 §15.3.1; our own application", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If original disclosures are supplied, record funding and operational/author roles for each report.", "current_reports": [ "R01", "R03", "R04" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "CAMELLIA was fully funded by Eisai, with sponsor co-design/manuscript participation and company-affiliated authors. BLOOM is described as sharing a developer program and overlapping funding/authors. The maintenance-trial funding value is “reported in the original text”.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. The maintenance trial’s specific sponsor and complete COI/data access for each report are unverified.", "missingness": "The maintenance trial’s specific sponsor and complete COI/data access for each report are unverified.", "uncertainty": "Do not convert “reported in the original text” to full-text reading in this production or establishment of a specific sponsor. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original report-specific funding, product provision, analysis/reporting, author affiliations and COI disclosures" }, { "item_id": "N42", "question_type": "Evidence condition", "question": "How much of the FDA review paper was actually read?", "needed": "Paper full text, citation/review context and original conflict-of-interest disclosures", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: How much of the FDA review paper was actually read?", "application_exception": "Do not claim FDA communication values were directly read in the paper because its title mentions the same trial.", "criterion": "Retain original citation/no-abstract labels and unread status.", "basis": "M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and the hyperlink contract are Chamgap design / M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design / Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If the user supplies the original full text, record material actually read separately from the FDA communication/summary.", "current_reports": [ "R02" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "A citation exists for Sharretts et al., PMID 32905671, and its original flag is “no abstract; do not guess content”. The external paper was not read in this production.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. The paper’s own content, direct results and disclosures remain unread.", "missingness": "The paper’s own content, direct results and disclosures remain unread.", "uncertainty": "Do not claim FDA communication values were directly read in the paper because its title mentions the same trial. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Paper full text, citation/review context and original conflict-of-interest disclosures" }, { "item_id": "N43", "question_type": "Evidence condition", "question": "Is extension to other weight-loss drugs or the class avoided?", "needed": "Direct product/mechanism/harm-specific material and comparison scope", "role": "Supplementary", "role_reason": "A condition for separately recording original information and gaps for: Is extension to other weight-loss drugs or the class avoided?", "application_exception": "Do not apply lorcaserin results to other products or the whole class, or create new treatment-selection instructions.", "criterion": "Retain original extension limitations and do not mix results from other products.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap design / M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design / M03 §3.2.4; Chamgap extension boundary / Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If material for a separate question is supplied, write each product’s original context separately.", "current_reports": [ "R01" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original advertising discussion explains distinct withdrawal reasons: fenfluramine valvulopathy, sibutramine cardiovascular harms and rimonabant psychiatric harms. These are not direct lorcaserin cardiovascular-superiority material.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Direct event effects and comparative harms of other products/classes are outside this material’s scope.", "missingness": "Direct event effects and comparative harms of other products/classes are outside this material’s scope.", "uncertainty": "Do not apply lorcaserin results to other products or the whole class, or create new treatment-selection instructions. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct product/mechanism/harm-specific material and comparison scope" }, { "item_id": "N44", "question_type": "Evidence condition", "question": "Are the reference date, corrections, Korean/English text and empty-value history preserved?", "needed": "Original dates, corrections, current update scope and original empty values", "role": "Required", "role_reason": "A condition for separately recording original information and gaps for: Are the reference date, corrections, Korean/English text and empty-value history preserved?", "application_exception": "Do not borrow the existing reference date as a current review date or convert an empty corrections array to certification that no corrections exist anywhere.", "criterion": "Link original languages, dates and empty values with the actual current reading scope.", "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design / M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are our own design", "condition_origin": "Production based on original materials; existing content review remains incomplete", "proposed_research": "If actual update material is supplied, distinguish the original version and a new correction event.", "current_reports": [ "R01", "R02", "R03", "R04", "R05" ], "existence": "Original stored-summary/citation links; existence and content of required external details unverified", "acquired_read": "Summary read; external materials not read", "observation": "The reference date 2026-08-26, empty corrections array, empty deliberation string, Korean/English text and null/false/empty-string parent-axis values are preserved. Historical marketing/verdict wording is not new current verification.", "condition_status": "Partly verified", "status_reason": "Partial verification links original stored-summary wording for production; clinical review or verification is not complete. Separate evidence-cutoff/facets keys are absent, and no external latest correction, withdrawal or authorization-status lookup was performed.", "missingness": "Separate evidence-cutoff/facets keys are absent, and no external latest correction, withdrawal or authorization-status lookup was performed.", "uncertainty": "Do not borrow the existing reference date as a current review date or convert an empty corrections array to certification that no corrections exist anywhere. Review of the existing content remains incomplete, and external originals were not checked.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original dates, corrections, current update scope and original empty values" } ], "reports": [ { "report_id": "R01", "title": "Bohula EA, Wiviott SD, McGuire DK, et al. Cardiovascular Safety of Lorcaserin in Overweight or Obese Patients. N Engl J Med. 2018;379:1107-1117. 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One-year weight response is separate context.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy", "access_status": "Local preserved summary acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T17:15:31.996394+09:00", "qualification": "The corresponding evidence-list/citation entry and parent original summary were linked for production. External originals remain unread." }, { "material_type": "External abstract", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "External abstract slot preserving the original source link; no current access, reading or link verification was performed." }, { "material_type": "External full text", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original source link connects identity/material and does not mean direct full-text acquisition or current content reading." }, { "material_type": "External registration", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the original NCT02019264 string is preserved; registration content, timing and prespecified definitions remain unread." }, { "material_type": "Required material: protocol/review methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required scope: MACE/MACE+ definitions, testing hierarchy, models, denominators/follow-up, harms and funding roles; existence, availability and acquisition of original material are unverified." }, { "material_type": "Required material: SAP and analysis methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Actual analysis material for the report, including endpoint hierarchy, models, aggregation/censoring and missing data, is needed and currently unread." }, { "material_type": "Required material: outcomes, denominators, and harms", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Details of this material’s MACE/MACE+ definitions, testing hierarchy, models, denominators/follow-up, harms and funding roles are needed. Results or denominators from other reports are not copied." }, { "material_type": "Required materials: funding and COI", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original disclosures and funding/author/review roles were not directly read. Original summary funding/affiliation history is distinguished from current reading of disclosures." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/30145941/" } ] }, { "report_id": "R02", "title": "Sharretts J, Galescu O, Gomatam S, et al. Cancer Risk Associated with Lorcaserin—The FDA's Review of the CAMELLIA-TIMI 61 Trial. N Engl J Med. 2020;383:1000-1002. 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Direct paper results remain unread; FDA communication values are not attributed as directly read paper content.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy", "access_status": "Local preserved summary acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T17:15:31.996394+09:00", "qualification": "Only citation entry 1 and the existence of the related citation in the stored summary were read. The no-abstract/do-not-guess labels were retained and direct paper content was not created." }, { "material_type": "External abstract", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original flag is no abstract. This is an existing record; no current access occurred and paper content was not guessed." }, { "material_type": "External full text", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original source link connects identity/material and does not mean direct full-text acquisition or current content reading." }, { "material_type": "External registration", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "This citation has no direct registration field; its mention of the same trial in the title is not used to fill a report-specific NCT field." }, { "material_type": "Required material: protocol/review methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required scope: paper full text, original disclosures, actual review content and relationships with the communication/summary; existence, availability and acquisition of original material are unverified." }, { "material_type": "Required material: SAP and analysis methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Actual analysis material for the report, including endpoint hierarchy, models, aggregation/censoring and missing data, is needed and currently unread." }, { "material_type": "Required material: outcomes, denominators, and harms", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Details of this material’s paper full text, original disclosures, actual review content and relationships with the communication/summary are needed. Results or denominators from other reports are not copied." }, { "material_type": "Required materials: funding and COI", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original disclosures and funding/author/review roles were not directly read. Original summary funding/affiliation history is distinguished from current reading of disclosures." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/32905671/" } ] }, { "report_id": "R03", "title": "Smith SR, Weissman NJ, Anderson CM, et al. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010. PMID: 20647200.", "url": "https://pubmed.ncbi.nlm.nih.gov/20647200/", "report_type": "BLOOM weight-loss trial report", "existence": "Report entry in the original preserved citations/summary", "acquired_read": "Summary read; external materials not read", "study_family": "F02", "independent_replication": false, "observed_result": "3,182 randomized participants; at least 5% loss at 52 weeks: 47.5% versus 20.3%; one-year retention: 55.4% (883/1595) versus 45.1% (716/1587). These are not repurposed as direct results for selected cardiovascular superiority.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy", "access_status": "Local preserved summary acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T17:15:31.996394+09:00", "qualification": "The corresponding evidence-list/citation entry and parent original summary were linked for production. External originals remain unread." }, { "material_type": "External abstract", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "External abstract slot preserving the original source link; no current access, reading or link verification was performed." }, { "material_type": "External full text", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original source link connects identity/material and does not mean direct full-text acquisition or current content reading." }, { "material_type": "External registration", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original registration-identifier value “not applicable” is preserved unchanged; actual registration information and content are unverified." }, { "material_type": "Required material: protocol/review methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required scope: weight-analysis/retention denominators, missing data, registration and funding/author relationships; existence, availability and acquisition of original material are unverified." }, { "material_type": "Required material: SAP and analysis methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Actual analysis material for the report, including endpoint hierarchy, models, aggregation/censoring and missing data, is needed and currently unread." }, { "material_type": "Required material: outcomes, denominators, and harms", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Details of this material’s weight-analysis/retention denominators, missing data, registration and funding/author relationships are needed. Results or denominators from other reports are not copied." }, { "material_type": "Required materials: funding and COI", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original disclosures and funding/author/review roles were not directly read. Original summary funding/affiliation history is distinguished from current reading of disclosures." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/20647200/" } ] }, { "report_id": "R04", "title": "Wadden TA, Walsh OA, Berkowitz RI, et al. A Randomized Trial of Lorcaserin and Lifestyle Counseling for Maintaining Weight Loss…. 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Not direct cardiovascular-event results.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy", "access_status": "Local preserved summary acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T17:15:31.996394+09:00", "qualification": "The corresponding evidence-list/citation entry and parent original summary were linked for production. External originals remain unread." }, { "material_type": "External abstract", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "External abstract slot preserving the original source link; no current access, reading or link verification was performed." }, { "material_type": "External full text", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original source link connects identity/material and does not mean direct full-text acquisition or current content reading." }, { "material_type": "External registration", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original registration-identifier value “not applicable” is preserved unchanged; actual registration information and content are unverified." }, { "material_type": "Required material: protocol/review methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required scope: time-specific co-primary outcomes/denominators, meaning of ±, 52-week intervals, plans and registration/funding; existence, availability and acquisition of original material are unverified." }, { "material_type": "Required material: SAP and analysis methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Actual analysis material for the report, including endpoint hierarchy, models, aggregation/censoring and missing data, is needed and currently unread." }, { "material_type": "Required material: outcomes, denominators, and harms", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Details of this material’s time-specific co-primary outcomes/denominators, meaning of ±, 52-week intervals, plans and registration/funding are needed. Results or denominators from other reports are not copied." }, { "material_type": "Required materials: funding and COI", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original disclosures and funding/author/review roles were not directly read. Original summary funding/affiliation history is distinguished from current reading of disclosures." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/29288545/" } ] }, { "report_id": "R05", "title": "US Food and Drug Administration. FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. 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The 2020-02-13 FDA request and Eisai US withdrawal are original history; no current communication/marketing lookup was performed.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy", "access_status": "Local preserved summary acquired", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T17:15:31.996394+09:00", "qualification": "The corresponding evidence-list/citation entry and parent original summary were linked for production. External originals remain unread." }, { "material_type": "External communication content", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "External FDA communication summary/content slot. It is not a PubMed paper abstract, and no current access or reading occurred." }, { "material_type": "External original communication", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original source link connects identity/material and does not mean direct full-text acquisition or current content reading." }, { "material_type": "External registration", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the original NCT02019264 string is preserved; registration content, timing and prespecified definitions remain unread." }, { "material_type": "Required material: protocol/review methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Required scope: original communication/regulatory text, cancer definitions/collection, people/cancer/time denominators and original judgments/uncertainty; existence, availability and acquisition of original material are unverified." }, { "material_type": "Required material: SAP and analysis methods", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Actual analysis material for the report, including endpoint hierarchy, models, aggregation/censoring and missing data, is needed and currently unread." }, { "material_type": "Required material: outcomes, denominators, and harms", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Details of this material’s original communication/regulatory text, cancer definitions/collection, people/cancer/time denominators and original judgments/uncertainty are needed. Results or denominators from other reports are not copied." }, { "material_type": "Required materials: funding and COI", "public_status": "Current public availability and detailed existence remain unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original disclosures and funding/author/review roles were not directly read. Original summary funding/affiliation history is distinguished from current reading of disclosures." } ], "links": [ { "label": "Official source", "url": "https://www.fda.gov/media/135189/download" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Review of existing content or actual review incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The original CAMELLIA trial and FDA safety reanalysis/related paper and communication concern the same population. R02 connects only the title/citation, retaining no abstract/do not guess content; it is not added as a separate efficacy or harm replication. BLOOM is original weight-trial context sharing a developer program, funding and authors with CAMELLIA, without new independent-replication certification. The selected maintenance trial after a low-calorie diet supplies time-specific/co-primary context, not CAMELLIA cardiovascular populations/results." }, "history": [ { "date": "2026-10-11", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "A public view and materials were prepared from the existing 44 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-11" }