Lorcaserin × At least 5% weight loss at one year — Evidence sheet separating response, maintenance and cancer reanalysis

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Comparative efficacyAre the selected one-year 5% response and the parent long-term weight verdict distinguished?Required	The subclaim is “At least 5% weight loss at one year”, with original grade C and a note of 38.7% versus 17.4%, P<0.001. The parent has grade C, 50 points and a safety warning. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No subclaim score, status or assessment axes are recorded; parent values are not repurposed as a subclaim score. No new verdict was made.	Separate records of the subclaim, verdict and parent context	If additional evidence is linked, incorporate it with the subclaim distinguished from the parent long-term and safety context.
2	Partly verified	Full text not readStored summary read	N02 · Comparative efficacyAre the actual participants and recruitment scope for the one-year response question preserved?Required	The CAMELLIA citation identifies participants with overweight or obesity, and the stored summary records 12,000 randomized participants. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Specific eligibility criteria by age, BMI, cardiovascular risk and baseline weight are absent from the stored summary. They are not transferred to other populations.	Original eligibility, baseline risk and denominator material for participants with obesity or overweight	Obtain the original tables of trial eligibility, baseline characteristics and the one-year analysis population.
3	Partly verified	Full text not readStored summary read	N03 · Comparative efficacyWhat were the study intervention, placebo, accompanying care and actual exposure?Required	The original intervention is long-term lorcaserin use, and CAMELLIA is double-blind and placebo-controlled. The drug is recorded as a serotonin 2C receptor agonist for weight loss. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Specific dose, formulation, adherence and accompanying lifestyle counseling are not supplied in the summary, so no new medication instructions are created.	Study records of the original formulation, dose, exposure, placebo and lifestyle care	Preserve actual intervention, placebo, exposure and accompanying-care material from the original protocol.
4	Partly verified	Full text not readStored summary read	N04 · Comparative efficacyAre the one-year response definition of at least 5% and its measurement unit directly specified?Required	The original endpoint is “At least 5% weight loss at one year”. The subclaim note and weight response in the CAMELLIA evidence list correspond to the same question. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The precise analysis definition, including baseline, weight measurement procedures and missing data in response determination, remains unread.	Original material on baseline weight, measurement time, response determination and analysis unit	Link the response definition and measurement times from the original report and protocol.
5	Partly verified	Full text not readStored summary read	N05 · Comparative efficacyAre the randomization denominator and the one-year response analysis denominator the same information?Required	CAMELLIA allocated 12,000 participants in groups of 6,000, with median follow-up of 3.3 years. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The 6,000 per arm are not asserted to be the one-year response analysis denominators or responder counts, which are not directly supplied. Event counts are not calculated from response percentages.	Arm-specific denominators for allocation, analysis, attrition and missing data	Obtain original one-year arm-specific analysis populations, observed participant counts, responders and missing-data handling.
6	Partly verified	Full text not readStored summary read	N06 · Comparative efficacyAre 38.7% versus 17.4% and the P value preserved as originally recorded?Required	CAMELLIA records at least 5% weight loss at one year as 38.7% versus 17.4%, P<0.001. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No response difference, RR, OR, NNT or new CI is calculated. The original between-group effect size and CI for weight response are absent from this summary.	Original arm-specific one-year response percentages, between-group effects, CIs and tests	Link the original between-group estimates, CIs, tests and analysis denominators when supplied.
7	Partly verified	Full text not readStored summary read	N07 · Comparative efficacyAre the prespecified weight-response hierarchy and the primary cardiovascular design distinguished?Required	CAMELLIA is designed as a randomized cardiovascular noninferiority trial; the stored summary records MACE safety and MACE+ efficacy as primary endpoints. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The one-year weight response is not promoted to a primary efficacy endpoint without separate evidence. Its hierarchy, adjustments and SAP remain unread.	Weight-endpoint prespecification, testing hierarchy and multiplicity plan	Link the position and testing order of the weight endpoint in the registration, protocol and SAP.
8	Partly verified	Full text not readStored summary read	N08 · Comparative efficacyAre randomization, blinding and outcome-analysis procedures preserved?Required	The source explicitly describes CAMELLIA as a multicenter, double-blind, placebo-controlled randomized trial. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Actual allocation concealment, analyst blinding and weight measurement procedures remain unread. A double-blind designation does not certify that all bias is resolved.	Original records of allocation concealment, blinding, analysts and measurement methods	Obtain the original methods, analysis plan, analysis populations and procedures.
9	Unverified	Full text not readStored summary read	N09 · Comparative efficacyCan the relationship of one-year missing data, discontinuation and adherence to the effect be directly checked?Required	CAMELLIA randomization counts and median follow-up are available, but details of attrition, adherence and alternative analyses for the one-year response are absent from this summary. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. BLOOM retention percentages are not transferred as CAMELLIA missing-data percentages.	Arm-specific adherence, discontinuation, missing-data reasons, adjustments and sensitivity material	Obtain original CAMELLIA one-year observation, discontinuation, missing-data handling and sensitivity-analysis tables.
10	Partly verified	Full text not readStored summary read	N10 · Comparative efficacyIs the BLOOM 52-week response distinguished from repeated measurements in the same trial?Required	BLOOM is a randomized placebo-controlled trial of 3,182 participants, recording at least 5% weight loss at 52 weeks as 47.5% versus 20.3%. It is a separate trial report from CAMELLIA. R03	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The two trials’ response percentages are not pooled, and the original record of the same developer program is preserved. A shared population or analysis method is unverified.	Each trial’s identity, participants, comparison, time point and denominator	Link each trial’s 52-week or one-year definition, denominator, intervention and participants separately.
11	Partly verified	Full text not readStored summary read	N11 · Comparative efficacyAre BLOOM’s low retention and the response analysis denominator distinguished?Required	BLOOM one-year retention is 55.4% (883/1595) versus 45.1% (716/1587). R03	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Retained participants are not converted to 5% responder counts. Analysis methods, missing-data handling and CIs for the summary response percentages remain unread, and no new attrition percentage is calculated.	Original arm-specific retention, analysis and missing-data material	Obtain the original report’s analysis populations, missing-data handling, sensitivity analyses and responder tables.
12	Partly verified	Full text not readStored summary read	N12 · Comparative efficacyAre the weight trials independent replications with different funding sources and research teams?Required	The stored summary states that BLOOM and CAMELLIA share a developer program with overlapping funding and authors, are not independent replications, and retain the existing R1 assessment axis. R01 R03	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Separate reports or different trials are not promoted to new certification of independent teams or funding sources. The final independent-trial count is null.	Original links among trials, development programs, funding and author overlap	Preserve original funding, team and analysis-role material separately; connect any verdict update to a user decision.
13	Partly verified	Full text not readStored summary read	N13 · Comparative efficacyDoes the maintenance trial after a low-calorie diet use the same comparison as the initial one-year response question?Required	The Wadden maintenance trial randomized 137 participants who had lost at least 5% through a low-calorie diet. Its selection conditions differ from the initial weight-loss response question. R04	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The maintenance response is not transferred to a one-year 5% response among people first starting drug treatment.	Weight-loss entry conditions, maintenance intervention, comparison and denominator	Obtain original entry weight loss, maintenance definitions, selected participants, arm-specific denominators and counseling/intervention components.
14	Partly verified	Full text not readStored summary read	N14 · Comparative efficacyAre the maintenance trial’s 24-week results and 52-week co-primary results separated?Required	At 24 weeks, at least 5% maintenance was 73.9% versus 57.4% (P=0.033), with additional −2.4±0.8 kg versus +0.6±0.8 kg (P=0.010). Both 52-week co-primary results are recorded as showing no between-group difference. R04	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Positive 24-week results are not repurposed as sustained superiority at 52 weeks. The statistical meaning of ±, 52-week effects, CIs, P values and arm-specific analysis denominators are absent from the summary.	Time-specific original effects, co-primary endpoints, CIs and analysis hierarchy	Obtain original estimates and CIs, missing-data handling and multiplicity plans for each co-primary endpoint and time point.
15	Partly verified	Full text not readStored summary read	N15 · Comparative efficacyHas weight loss avoided being extended to prevention of clinical cardiovascular events?Required	The stored summary records weight as a surrogate for clinical events and states that MACE+ superiority was null. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The one-year 5% response is not converted to proof of cardiovascular prevention, survival benefit or cancer safety.	Separate direct results for the weight surrogate and clinical events	Link direct definitions, effects, CIs and follow-up for each clinical-event outcome as separate questions.
16	Partly verified	Full text not readStored summary read	N16 · Supplementary harm evidenceAre MACE safety noninferiority, weight efficacy and cancer safety distinguished?Required	MACE was 364 participants (6.1%) versus 369 (6.2%), HR 0.99 (95% CI 0.85~1.14), recorded as meeting the prespecified noninferiority margin of HR 1.40. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. These values are not weight-response effects or CIs and do not substitute for cancer safety.	Original endpoint-specific prespecified margins, estimates, events and follow-up	Link the MACE noninferiority plan and direct material for other harm endpoints separately.
17	Partly verified	Full text not readStored summary read	N17 · Comparative efficacyHas null MACE+ superiority avoided being converted to a null weight response?Required	MACE+ is recorded as 707 participants (11.8%) versus 727 (12.1%), HR 0.97 (0.87~1.07), P=0.55. R01	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Weight response and clinical-event effects are not mixed. No new CI level is attached to the MACE+ interval in this summary.	Events, estimates and tests for distinct efficacy endpoints	Link endpoint definitions, the prespecified superiority plan and the weight-response hierarchy using original material.
18	Partly verified	Full text not readStored summary read	N18 · Comparative efficacyAre manufacturer support, affiliated authors, design and manuscript roles separated?Required	Full Eisai funding, company-affiliated authors, and sponsor participation in co-design and manuscript preparation are recorded. Funding and author overlap with BLOOM is also preserved. R01 R03	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Free product provision, outsourced analysis and each author’s detailed roles are not established by the summary. Company manuscript participation is not equated with outsourced analysis.	Separate records of cash funding, product provision, employee authors and external analysis roles	Obtain original disclosures of funding, products, affiliations, data access, analysis and manuscript roles separately.
19	Unverified	Full text not readStored summary read	N19 · Comparative efficacyHas the maintenance trial’s funding label avoided being converted to certification of a specific sponsor?Required	The Wadden evidence-list funding entry is preserved only as “reported in the original text”. R04	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. This ambiguous original label does not newly establish public funding, absence of corporate funding or independent replication.	Actual maintenance-trial funding, product, author and analysis records	Obtain the maintenance trial’s originally disclosed interests and research roles for each source.
20	Partly verified	Full text not readStored summary read	N20 · Comparative efficacyDo the FDA cancer reanalysis and CAMELLIA efficacy report concern the same trial data?Required	The 2020 FDA reanalysis is recorded as concerning the same 12,000 CAMELLIA participants. The FDA review paper and FDA safety communication are linked as separate report entries. R01 R02 R05	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The reanalysis paper and regulatory document are not added as separate efficacy trials or new participant populations. Full-text content is not guessed.	Relationships among the original trial, completed reanalysis, regulatory documents and paper reports	Link completed reanalysis material and the result sources for each report.
21	Partly verified	Full text not readStored summary read	N21 · Supplementary harm evidenceAre people diagnosed with cancer, primary cancers and patient-years preserved as different units?Required	The FDA summary records 462 lorcaserin participants (7.7%, 520 primary cancers) versus 423 placebo participants (7.1%, 470 cancers), with approximately one additional cancer per 470 patient-years. R02 R05	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. People, tumors and patient-years are not added together, and no new risk difference, NNH or HR is calculated. Arm-specific patient-years are unverified.	Original harm-event definitions, people, tumors, observation time and denominators	Obtain original tables of cancer-event definitions, repeated primary cancers, exposure time and denominators.
22	Partly verified	Full text not readStored summary read	N22 · Supplementary harm evidenceAre cancer-signal timing, cancer types and statistical confirmation distinguished?Required	The stored summary records a widening difference over time, with imbalances in pancreatic, colorectal and lung cancers contributing. It states that the public FDA communication did not supply an overall cancer risk ratio, CI or P value. R02 R05	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The regulatory decision is not converted to new statistical certification of overall cancer significance. Time-specific or cancer-type-specific values and CIs are not created.	Cancer-type and duration-specific effects, CIs, P values, plans and regulatory decisions	Link completed event tables, prespecified plans, duration-specific estimates and the basis for regulatory decisions separately.
23	Partly verified	Full text not readStored summary read	N23 · Supplementary harm evidenceAre a prespecified clinical cancer threshold and the weight-response threshold the same?Required	The stored summary records no declared prespecified clinical cancer threshold. The 5% threshold is the selected weight-response definition. R01 R05	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The 5% response definition is not transferred to an acceptable cancer-risk or benefit–harm threshold. No new threshold is created.	Prespecified importance and analysis plans for each efficacy and harm endpoint	Preserve the plans and importance judgments for cancer and weight separately.
24	Partly verified	Full text not readStored summary read	N24 · Supplementary harm evidenceAre the market-withdrawal record and efficacy grade preserved together?Required	The preserved summary records the FDA request for voluntary withdrawal on February 13, 2020 and Eisai’s US market withdrawal, and explicitly states that weight grade C and 50 points do not mean that the drug is okay to take. R05	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Current regulatory status was not newly looked up in this production. Efficacy benefit alone is not converted to availability or medication advice.	Separate records of regulatory-event dates, scope, decisions and clinical efficacy	If new regulatory material is supplied, link its original text, date and change event separately.
25	Partly verified	Full text not readStored summary read	N25 · Supplementary harm evidenceHave withdrawal reasons for other serotonergic drugs avoided being repurposed?Required	The stored summary explains that fenfluramine valvulopathy, sibutramine cardiovascular harms and rimonabant psychiatric harms differ from the reason for lorcaserin withdrawal. R05	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Lorcaserin results are not extended to class-wide efficacy or cancer harms, and harms of other drugs are not used as lorcaserin values.	Direct distinctions among drug-specific efficacy, harms and regulatory events	If direct drug-specific material is supplied, link it with questions, participants and endpoints separated.
26	Unverified	Full text not readStored summary read	N26 · Supplementary harm evidenceDo gaps remain for other harms, discontinuation and long-term exposure?Required	The parent safety status is Warning, and the preserved explanation focuses on cancer reanalysis and MACE. R01 R02 R05	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Detailed tables of other adverse events, discontinuation and drug exposure were not newly checked and are not filled in as safe.	Arm-specific material on all harms, serious events, discontinuation reasons and exposure denominators	Original safety collection, arm-specific events, discontinuation, exposure and long-term material are needed.
27	Partly verified	Full text not readStored summary read	N27 · Supplementary harm evidenceAre the scope of safety reanalysis and independent harm replication distinguished?Required	The stored summary explicitly states that the FDA reanalysis is a safety review of the same CAMELLIA trial and is not counted as a separate efficacy trial. R01 R02 R05	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Other harm replication or incidence material was not looked up, and independence was not established, in this production.	Relationships between reanalysis of the same trial and independent external harm material	If external harm material is supplied, link trial, exposure, population and denominator relationships separately.
28	Partly verified	Full text not readStored summary read	N28 · Comparative efficacyAre citation URLs, no-abstract labels and unread full text distinguished?Required	Five citation URLs are linked as preserved in the source. The original flag for FDA review paper PMID 32905671 is “no abstract; do not guess content”. All external sources remain unread in this production. R01 R02 R03 R04 R05	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. A URL is not promoted to acquisition of an abstract or full text; content from another document is not transferred and marked as a reading of the FDA paper.	Separate actual-access records for papers, regulatory documents and stored summaries	Link originals obtained by the user for each source and record actual access status.
29	Partly verified	Full text not readStored summary read	N29 · Comparative efficacyAre registration identifiers and reading of registrations, protocols and SAPs separated?Required	The CAMELLIA and FDA reanalysis evidence-list identifiers are both NCT02019264. The original registration-identifier values for BLOOM and the maintenance trial are “not applicable”. R01 R02 R03 R04	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No registration URL is in the source, so no new URL is invented and marked as accessed. “Not applicable” is not converted to new certification that no registration exists.	Directly preserved registration, protocol and SAP material for each trial	If original registrations, protocols and SAPs are supplied, link them to each trial.
30	Partly verified	Full text not readStored summary read	N30 · Comparative efficacyAre the reference date, corrections, Korean and English manuscripts and parent axes preserved in their original form?Required	The full stored-summary copy preserves the reference date 2026-08-26, empty correction history, Korean and English manuscripts, parent grade C, 50 points, Warning and original assessment axes. R01 R02 R03 R04 R05	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The production date is not converted to a new clinical evidence date, and stored-summary cross-checking language is not used as completion of this review.	Original verdict, language-specific wording, reference date and correction history	If new material arises, link preservation of the original text and a separate update event to review of the existing content.
31	Partly verified	Full text not readStored summary read	N31 · Comparative efficacyHas the selected response avoided being extended to all long-term weight loss, maintenance or clinical function?Required	The stored summary records inconsistent long-term maintenance results and weight as a surrogate in the context of the parent grade C verdict. R01 R03 R04	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The one-year response is not converted to benefit across all durations, populations, weight-loss maintenance or clinical events. Medication or lifestyle-care instructions are not created.	Direct distinctions between selected participants, duration and response and long-term maintenance or clinical outcomes	Link participants, comparators, time points, effects and harms suited to each long-term question separately.
32	Partly verified	Full text not readStored summary read	N32 · Comparative efficacyAre production completion, review of the existing content and independence certification separated?Supplementary	The current label is review of the existing content; active pending and completion flags for model/content/boundary are false. Original candidate-review pending and production-permitted labels are preserved as history. R01 R02 R03 R04 R05	Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No new structural unit or independent clinical certification was created. Final unique-trial and participant totals are not recorded.	Separate records of original candidate history, production status and review status	Incorporate only the user’s subsequent material or decisions as separate events.

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32 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: CAMELLIA participants with overweight or obesity; detailed eligibility and baseline-risk scope unread
Ingredient, formulation and route: Study of long-term lorcaserin use; not current usage instructions
Dose: No specific dose, formulation or adherence information in the source; no medication instructions created
Comparator: Placebo in CAMELLIA and BLOOM; Wadden compares maintenance after weight loss with a low-calorie diet
Measured outcome: At least 5% weight loss at one year; MACE, MACE+ and cancer are separate endpoints
Duration: Selected duration: one year; CAMELLIA median follow-up 3.3 years; BLOOM 52 weeks and maintenance-trial 24 and 52 weeks separated
Questions outside this scope: Converting the one-year response to clinical-event or survival benefits; Repurposing cardiovascular noninferiority as cancer safety; Converting an FDA regulatory decision to new statistical certification of overall cancer results; Medication, product or treatment instructions

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · 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. PMID: 30145941.

PubMed

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 5% weight loss: 38.7% versus 17.4%, P<0.001; MACE HR 0.99 (0.85~1.14); MACE+ HR 0.97 (0.87~1.07), P=0.55
Record level: Preserved review summary; not a result of actually reading external papers or communications
Study overlap and independent replication: Efficacy report, FDA reanalysis paper and regulatory communication from the same CAMELLIA trial; BLOOM is a separate trial sharing a development program, funding and authors with CAMELLIA; Wadden is a maintenance trial after weight loss, with a different question from the initial one-year response. Reports, reviews, reanalyses or the same population are not added as new independent trials or participants; family IDs connect relationships and do not certify a unique-trial count.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Original source link preserved	Summary read	Summary read	Preserved parent summary
abstract	Original source link preserved	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
fulltext	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
registration	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
protocol_sap	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review

R02 · 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. PMID: 32905671.

PubMed

Material type: Regulatory reanalysis report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 462 participants (7.7%, 520 cancers) versus 423 (7.1%, 470 cancers); approximately one additional cancer per 470 patient-years, with a widening difference over time
Record level: The evidence-list entry for FDA reanalysis of the same trial is linked as relational context; the original no-abstract label is preserved and the paper’s full-text results are not certified
Study overlap and independent replication: Efficacy report, FDA reanalysis paper and regulatory communication from the same CAMELLIA trial; BLOOM is a separate trial sharing a development program, funding and authors with CAMELLIA; Wadden is a maintenance trial after weight loss, with a different question from the initial one-year response. Reports, reviews, reanalyses or the same population are not added as new independent trials or participants; family IDs connect relationships and do not certify a unique-trial count.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Original source link preserved	Summary read	Summary read	Preserved parent summary
abstract	Original source link preserved	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
fulltext	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
registration	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
protocol_sap	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review

R03 · Smith SR, Weissman NJ, Anderson CM, et al. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010. PMID: 20647200.

PubMed

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 47.5% versus 20.3%; one-year retention 55.4% (883/1595) versus 45.1% (716/1587)
Record level: Preserved review summary; not a result of actually reading external papers or communications
Study overlap and independent replication: Efficacy report, FDA reanalysis paper and regulatory communication from the same CAMELLIA trial; BLOOM is a separate trial sharing a development program, funding and authors with CAMELLIA; Wadden is a maintenance trial after weight loss, with a different question from the initial one-year response. Reports, reviews, reanalyses or the same population are not added as new independent trials or participants; family IDs connect relationships and do not certify a unique-trial count.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Original source link preserved	Summary read	Summary read	Preserved parent summary
abstract	Original source link preserved	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
fulltext	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
registration	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
protocol_sap	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review

R04 · Wadden TA, Walsh OA, Berkowitz RI, et al. A Randomized Trial of Lorcaserin and Lifestyle Counseling for Maintaining Weight Loss…. PMID: 29288545.

PubMed

Material type: Trial report
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: At 24 weeks, at least 5% maintenance: 73.9% versus 57.4% (P=0.033), additional −2.4±0.8 kg versus +0.6±0.8 kg (P=0.010); both 52-week co-primary results show no between-group difference
Record level: Preserved review summary; not a result of actually reading external papers or communications
Study overlap and independent replication: Efficacy report, FDA reanalysis paper and regulatory communication from the same CAMELLIA trial; BLOOM is a separate trial sharing a development program, funding and authors with CAMELLIA; Wadden is a maintenance trial after weight loss, with a different question from the initial one-year response. Reports, reviews, reanalyses or the same population are not added as new independent trials or participants; family IDs connect relationships and do not certify a unique-trial count.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Original source link preserved	Summary read	Summary read	Preserved parent summary
abstract	Original source link preserved	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
fulltext	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
registration	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
protocol_sap	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review

R05 · US Food and Drug Administration. FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market. February 13, 2020.

Official source

Material type: Regulatory communication
Materials actually read: Summary read; external materials not read
Findings recorded in the stored summary: 462 participants (7.7%, 520 cancers) versus 423 (7.1%, 470 cancers); approximately one additional cancer per 470 patient-years, with a widening difference over time
Record level: Regulatory context preserved in the FDA reanalysis evidence list and existing review summary; not direct reading of the communication in this production
Study overlap and independent replication: Efficacy report, FDA reanalysis paper and regulatory communication from the same CAMELLIA trial; BLOOM is a separate trial sharing a development program, funding and authors with CAMELLIA; Wadden is a maintenance trial after weight loss, with a different question from the initial one-year response. Reports, reviews, reanalyses or the same population are not added as new independent trials or participants; family IDs connect relationships and do not certify a unique-trial count.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
local_summary	Original source link preserved	Summary read	Summary read	Preserved parent summary
abstract	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
fulltext	Original source link preserved	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
registration	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review
protocol_sap	No separate URL in the original material	Not read	Not read	External material unread; the presence or absence of a URL does not mean material acquisition or completed review

Report counts versus independent study counts

Efficacy report, FDA reanalysis paper and regulatory communication from the same CAMELLIA trial; BLOOM is a separate trial sharing a development program, funding and authors with CAMELLIA; Wadden is a maintenance trial after weight loss, with a different question from the initial one-year response. Reports, reviews, reanalyses or the same population are not added as new independent trials or participants; family IDs connect relationships and do not certify a unique-trial count.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Are the selected one-year 5% response and the parent long-term weight verdict distinguished?

Required materials and conditions: Separate records of the subclaim, verdict and parent context
Conditions for verification: Separate records of the subclaim, verdict and parent context
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N02 · Are the actual participants and recruitment scope for the one-year response question preserved?

Required materials and conditions: Original eligibility, baseline risk and denominator material for participants with obesity or overweight
Conditions for verification: Original eligibility, baseline risk and denominator material for participants with obesity or overweight
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N03 · What were the study intervention, placebo, accompanying care and actual exposure?

Required materials and conditions: Study records of the original formulation, dose, exposure, placebo and lifestyle care
Conditions for verification: Study records of the original formulation, dose, exposure, placebo and lifestyle care
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N04 · Are the one-year response definition of at least 5% and its measurement unit directly specified?

Required materials and conditions: Original material on baseline weight, measurement time, response determination and analysis unit
Conditions for verification: Original material on baseline weight, measurement time, response determination and analysis unit
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N05 · Are the randomization denominator and the one-year response analysis denominator the same information?

Required materials and conditions: Arm-specific denominators for allocation, analysis, attrition and missing data
Conditions for verification: Arm-specific denominators for allocation, analysis, attrition and missing data
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N06 · Are 38.7% versus 17.4% and the P value preserved as originally recorded?

Required materials and conditions: Original arm-specific one-year response percentages, between-group effects, CIs and tests
Conditions for verification: Original arm-specific one-year response percentages, between-group effects, CIs and tests
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N07 · Are the prespecified weight-response hierarchy and the primary cardiovascular design distinguished?

Required materials and conditions: Weight-endpoint prespecification, testing hierarchy and multiplicity plan
Conditions for verification: Weight-endpoint prespecification, testing hierarchy and multiplicity plan
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N08 · Are randomization, blinding and outcome-analysis procedures preserved?

Required materials and conditions: Original records of allocation concealment, blinding, analysts and measurement methods
Conditions for verification: Original records of allocation concealment, blinding, analysts and measurement methods
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N09 · Can the relationship of one-year missing data, discontinuation and adherence to the effect be directly checked?

Required materials and conditions: Arm-specific adherence, discontinuation, missing-data reasons, adjustments and sensitivity material
Conditions for verification: Arm-specific adherence, discontinuation, missing-data reasons, adjustments and sensitivity material
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N10 · Is the BLOOM 52-week response distinguished from repeated measurements in the same trial?

Required materials and conditions: Each trial’s identity, participants, comparison, time point and denominator
Conditions for verification: Each trial’s identity, participants, comparison, time point and denominator
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N11 · Are BLOOM’s low retention and the response analysis denominator distinguished?

Required materials and conditions: Original arm-specific retention, analysis and missing-data material
Conditions for verification: Original arm-specific retention, analysis and missing-data material
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N12 · Are the weight trials independent replications with different funding sources and research teams?

Required materials and conditions: Original links among trials, development programs, funding and author overlap
Conditions for verification: Original links among trials, development programs, funding and author overlap
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N13 · Does the maintenance trial after a low-calorie diet use the same comparison as the initial one-year response question?

Required materials and conditions: Weight-loss entry conditions, maintenance intervention, comparison and denominator
Conditions for verification: Weight-loss entry conditions, maintenance intervention, comparison and denominator
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N14 · Are the maintenance trial’s 24-week results and 52-week co-primary results separated?

Required materials and conditions: Time-specific original effects, co-primary endpoints, CIs and analysis hierarchy
Conditions for verification: Time-specific original effects, co-primary endpoints, CIs and analysis hierarchy
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N15 · Has weight loss avoided being extended to prevention of clinical cardiovascular events?

Required materials and conditions: Separate direct results for the weight surrogate and clinical events
Conditions for verification: Separate direct results for the weight surrogate and clinical events
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N16 · Are MACE safety noninferiority, weight efficacy and cancer safety distinguished?

Required materials and conditions: Original endpoint-specific prespecified margins, estimates, events and follow-up
Conditions for verification: Original endpoint-specific prespecified margins, estimates, events and follow-up
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N17 · Has null MACE+ superiority avoided being converted to a null weight response?

Required materials and conditions: Events, estimates and tests for distinct efficacy endpoints
Conditions for verification: Events, estimates and tests for distinct efficacy endpoints
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N18 · Are manufacturer support, affiliated authors, design and manuscript roles separated?

Required materials and conditions: Separate records of cash funding, product provision, employee authors and external analysis roles
Conditions for verification: Separate records of cash funding, product provision, employee authors and external analysis roles
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N19 · Has the maintenance trial’s funding label avoided being converted to certification of a specific sponsor?

Required materials and conditions: Actual maintenance-trial funding, product, author and analysis records
Conditions for verification: Actual maintenance-trial funding, product, author and analysis records
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N20 · Do the FDA cancer reanalysis and CAMELLIA efficacy report concern the same trial data?

Required materials and conditions: Relationships among the original trial, completed reanalysis, regulatory documents and paper reports
Conditions for verification: Relationships among the original trial, completed reanalysis, regulatory documents and paper reports
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N21 · Are people diagnosed with cancer, primary cancers and patient-years preserved as different units?

Required materials and conditions: Original harm-event definitions, people, tumors, observation time and denominators
Conditions for verification: Original harm-event definitions, people, tumors, observation time and denominators
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N22 · Are cancer-signal timing, cancer types and statistical confirmation distinguished?

Required materials and conditions: Cancer-type and duration-specific effects, CIs, P values, plans and regulatory decisions
Conditions for verification: Cancer-type and duration-specific effects, CIs, P values, plans and regulatory decisions
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N23 · Are a prespecified clinical cancer threshold and the weight-response threshold the same?

Required materials and conditions: Prespecified importance and analysis plans for each efficacy and harm endpoint
Conditions for verification: Prespecified importance and analysis plans for each efficacy and harm endpoint
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N24 · Are the market-withdrawal record and efficacy grade preserved together?

Required materials and conditions: Separate records of regulatory-event dates, scope, decisions and clinical efficacy
Conditions for verification: Separate records of regulatory-event dates, scope, decisions and clinical efficacy
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N25 · Have withdrawal reasons for other serotonergic drugs avoided being repurposed?

Required materials and conditions: Direct distinctions among drug-specific efficacy, harms and regulatory events
Conditions for verification: Direct distinctions among drug-specific efficacy, harms and regulatory events
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N26 · Do gaps remain for other harms, discontinuation and long-term exposure?

Required materials and conditions: Arm-specific material on all harms, serious events, discontinuation reasons and exposure denominators
Conditions for verification: Arm-specific material on all harms, serious events, discontinuation reasons and exposure denominators
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N27 · Are the scope of safety reanalysis and independent harm replication distinguished?

Required materials and conditions: Relationships between reanalysis of the same trial and independent external harm material
Conditions for verification: Relationships between reanalysis of the same trial and independent external harm material
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N28 · Are citation URLs, no-abstract labels and unread full text distinguished?

Required materials and conditions: Separate actual-access records for papers, regulatory documents and stored summaries
Conditions for verification: Separate actual-access records for papers, regulatory documents and stored summaries
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N29 · Are registration identifiers and reading of registrations, protocols and SAPs separated?

Required materials and conditions: Directly preserved registration, protocol and SAP material for each trial
Conditions for verification: Directly preserved registration, protocol and SAP material for each trial
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N30 · Are the reference date, corrections, Korean and English manuscripts and parent axes preserved in their original form?

Required materials and conditions: Original verdict, language-specific wording, reference date and correction history
Conditions for verification: Original verdict, language-specific wording, reference date and correction history
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N31 · Has the selected response avoided being extended to all long-term weight loss, maintenance or clinical function?

Required materials and conditions: Direct distinctions between selected participants, duration and response and long-term maintenance or clinical outcomes
Conditions for verification: Direct distinctions between selected participants, duration and response and long-term maintenance or clinical outcomes
Requirement and applicability: Required
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Referenced methods: At least 5% weight loss at one year

N32 · Are production completion, review of the existing content and independence certification separated?

Required materials and conditions: Separate records of original candidate history, production status and review status
Conditions for verification: Separate records of original candidate history, production status and review status
Requirement and applicability: Supplementary
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Why this condition is needed: Supplementary condition separating production status and scope of application
Referenced methods: At least 5% weight loss at one year

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed.

What the statuses mean

Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete: Review of existing content incomplete
Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible: Not applied during this preparation because actual access was not tested
Not applicable: Use with a reason for non-applicability based on an explicit question boundary
Conflicting data: Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

Change history

2026-10-11 · Public page/material version 1.0

Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Are the selected one-year 5% response and the parent long-term weight verdict distinguished?

Current findings: The subclaim is “At least 5% weight loss at one year”, with original grade C and a note of 38.7% versus 17.4%, P<0.001. The parent has grade C, 50 points and a safety warning.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No subclaim score, status or assessment axes are recorded; parent values are not repurposed as a subclaim score. No new verdict was made.
Reason for missing information: No subclaim score, status or assessment axes are recorded; parent values are not repurposed as a subclaim score. No new verdict was made.
Required materials and conditions: Separate records of the subclaim, verdict and parent context
Materials to obtain first: No subclaim score, status or assessment axes are recorded; parent values are not repurposed as a subclaim score. No new verdict was made.
Further research: If additional evidence is linked, incorporate it with the subclaim distinguished from the parent long-term and safety context.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate records of the subclaim, verdict and parent context
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N02 · Are the actual participants and recruitment scope for the one-year response question preserved?

Current findings: The CAMELLIA citation identifies participants with overweight or obesity, and the stored summary records 12,000 randomized participants.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Specific eligibility criteria by age, BMI, cardiovascular risk and baseline weight are absent from the stored summary. They are not transferred to other populations.
Reason for missing information: Specific eligibility criteria by age, BMI, cardiovascular risk and baseline weight are absent from the stored summary. They are not transferred to other populations.
Required materials and conditions: Original eligibility, baseline risk and denominator material for participants with obesity or overweight
Materials to obtain first: Specific eligibility criteria by age, BMI, cardiovascular risk and baseline weight are absent from the stored summary. They are not transferred to other populations.
Further research: Obtain the original tables of trial eligibility, baseline characteristics and the one-year analysis population.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original eligibility, baseline risk and denominator material for participants with obesity or overweight
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N03 · What were the study intervention, placebo, accompanying care and actual exposure?

Current findings: The original intervention is long-term lorcaserin use, and CAMELLIA is double-blind and placebo-controlled. The drug is recorded as a serotonin 2C receptor agonist for weight loss.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Specific dose, formulation, adherence and accompanying lifestyle counseling are not supplied in the summary, so no new medication instructions are created.
Reason for missing information: Specific dose, formulation, adherence and accompanying lifestyle counseling are not supplied in the summary, so no new medication instructions are created.
Required materials and conditions: Study records of the original formulation, dose, exposure, placebo and lifestyle care
Materials to obtain first: Specific dose, formulation, adherence and accompanying lifestyle counseling are not supplied in the summary, so no new medication instructions are created.
Further research: Preserve actual intervention, placebo, exposure and accompanying-care material from the original protocol.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Study records of the original formulation, dose, exposure, placebo and lifestyle care
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N04 · Are the one-year response definition of at least 5% and its measurement unit directly specified?

Current findings: The original endpoint is “At least 5% weight loss at one year”. The subclaim note and weight response in the CAMELLIA evidence list correspond to the same question.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The precise analysis definition, including baseline, weight measurement procedures and missing data in response determination, remains unread.
Reason for missing information: The precise analysis definition, including baseline, weight measurement procedures and missing data in response determination, remains unread.
Required materials and conditions: Original material on baseline weight, measurement time, response determination and analysis unit
Materials to obtain first: The precise analysis definition, including baseline, weight measurement procedures and missing data in response determination, remains unread.
Further research: Link the response definition and measurement times from the original report and protocol.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original material on baseline weight, measurement time, response determination and analysis unit
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N05 · Are the randomization denominator and the one-year response analysis denominator the same information?

Current findings: CAMELLIA allocated 12,000 participants in groups of 6,000, with median follow-up of 3.3 years.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The 6,000 per arm are not asserted to be the one-year response analysis denominators or responder counts, which are not directly supplied. Event counts are not calculated from response percentages.
Reason for missing information: The 6,000 per arm are not asserted to be the one-year response analysis denominators or responder counts, which are not directly supplied. Event counts are not calculated from response percentages.
Required materials and conditions: Arm-specific denominators for allocation, analysis, attrition and missing data
Materials to obtain first: The 6,000 per arm are not asserted to be the one-year response analysis denominators or responder counts, which are not directly supplied. Event counts are not calculated from response percentages.
Further research: Obtain original one-year arm-specific analysis populations, observed participant counts, responders and missing-data handling.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Arm-specific denominators for allocation, analysis, attrition and missing data
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N06 · Are 38.7% versus 17.4% and the P value preserved as originally recorded?

Current findings: CAMELLIA records at least 5% weight loss at one year as 38.7% versus 17.4%, P<0.001.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No response difference, RR, OR, NNT or new CI is calculated. The original between-group effect size and CI for weight response are absent from this summary.
Reason for missing information: No response difference, RR, OR, NNT or new CI is calculated. The original between-group effect size and CI for weight response are absent from this summary.
Required materials and conditions: Original arm-specific one-year response percentages, between-group effects, CIs and tests
Materials to obtain first: No response difference, RR, OR, NNT or new CI is calculated. The original between-group effect size and CI for weight response are absent from this summary.
Further research: Link the original between-group estimates, CIs, tests and analysis denominators when supplied.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original arm-specific one-year response percentages, between-group effects, CIs and tests
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N07 · Are the prespecified weight-response hierarchy and the primary cardiovascular design distinguished?

Current findings: CAMELLIA is designed as a randomized cardiovascular noninferiority trial; the stored summary records MACE safety and MACE+ efficacy as primary endpoints.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The one-year weight response is not promoted to a primary efficacy endpoint without separate evidence. Its hierarchy, adjustments and SAP remain unread.
Reason for missing information: The one-year weight response is not promoted to a primary efficacy endpoint without separate evidence. Its hierarchy, adjustments and SAP remain unread.
Required materials and conditions: Weight-endpoint prespecification, testing hierarchy and multiplicity plan
Materials to obtain first: The one-year weight response is not promoted to a primary efficacy endpoint without separate evidence. Its hierarchy, adjustments and SAP remain unread.
Further research: Link the position and testing order of the weight endpoint in the registration, protocol and SAP.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Weight-endpoint prespecification, testing hierarchy and multiplicity plan
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N08 · Are randomization, blinding and outcome-analysis procedures preserved?

Current findings: The source explicitly describes CAMELLIA as a multicenter, double-blind, placebo-controlled randomized trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Actual allocation concealment, analyst blinding and weight measurement procedures remain unread. A double-blind designation does not certify that all bias is resolved.
Reason for missing information: Actual allocation concealment, analyst blinding and weight measurement procedures remain unread. A double-blind designation does not certify that all bias is resolved.
Required materials and conditions: Original records of allocation concealment, blinding, analysts and measurement methods
Materials to obtain first: Actual allocation concealment, analyst blinding and weight measurement procedures remain unread. A double-blind designation does not certify that all bias is resolved.
Further research: Obtain the original methods, analysis plan, analysis populations and procedures.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original records of allocation concealment, blinding, analysts and measurement methods
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N09 · Can the relationship of one-year missing data, discontinuation and adherence to the effect be directly checked?

Current findings: CAMELLIA randomization counts and median follow-up are available, but details of attrition, adherence and alternative analyses for the one-year response are absent from this summary.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. BLOOM retention percentages are not transferred as CAMELLIA missing-data percentages.
Reason for missing information: BLOOM retention percentages are not transferred as CAMELLIA missing-data percentages.
Required materials and conditions: Arm-specific adherence, discontinuation, missing-data reasons, adjustments and sensitivity material
Materials to obtain first: BLOOM retention percentages are not transferred as CAMELLIA missing-data percentages.
Further research: Obtain original CAMELLIA one-year observation, discontinuation, missing-data handling and sensitivity-analysis tables.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Arm-specific adherence, discontinuation, missing-data reasons, adjustments and sensitivity material
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N10 · Is the BLOOM 52-week response distinguished from repeated measurements in the same trial?

Current findings: BLOOM is a randomized placebo-controlled trial of 3,182 participants, recording at least 5% weight loss at 52 weeks as 47.5% versus 20.3%. It is a separate trial report from CAMELLIA.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The two trials’ response percentages are not pooled, and the original record of the same developer program is preserved. A shared population or analysis method is unverified.
Reason for missing information: The two trials’ response percentages are not pooled, and the original record of the same developer program is preserved. A shared population or analysis method is unverified.
Required materials and conditions: Each trial’s identity, participants, comparison, time point and denominator
Materials to obtain first: The two trials’ response percentages are not pooled, and the original record of the same developer program is preserved. A shared population or analysis method is unverified.
Further research: Link each trial’s 52-week or one-year definition, denominator, intervention and participants separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Each trial’s identity, participants, comparison, time point and denominator
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R03

N11 · Are BLOOM’s low retention and the response analysis denominator distinguished?

Current findings: BLOOM one-year retention is 55.4% (883/1595) versus 45.1% (716/1587).
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Retained participants are not converted to 5% responder counts. Analysis methods, missing-data handling and CIs for the summary response percentages remain unread, and no new attrition percentage is calculated.
Reason for missing information: Retained participants are not converted to 5% responder counts. Analysis methods, missing-data handling and CIs for the summary response percentages remain unread, and no new attrition percentage is calculated.
Required materials and conditions: Original arm-specific retention, analysis and missing-data material
Materials to obtain first: Retained participants are not converted to 5% responder counts. Analysis methods, missing-data handling and CIs for the summary response percentages remain unread, and no new attrition percentage is calculated.
Further research: Obtain the original report’s analysis populations, missing-data handling, sensitivity analyses and responder tables.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original arm-specific retention, analysis and missing-data material
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R03

N12 · Are the weight trials independent replications with different funding sources and research teams?

Current findings: The stored summary states that BLOOM and CAMELLIA share a developer program with overlapping funding and authors, are not independent replications, and retain the existing R1 assessment axis.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Separate reports or different trials are not promoted to new certification of independent teams or funding sources. The final independent-trial count is null.
Reason for missing information: Separate reports or different trials are not promoted to new certification of independent teams or funding sources. The final independent-trial count is null.
Required materials and conditions: Original links among trials, development programs, funding and author overlap
Materials to obtain first: Separate reports or different trials are not promoted to new certification of independent teams or funding sources. The final independent-trial count is null.
Further research: Preserve original funding, team and analysis-role material separately; connect any verdict update to a user decision.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original links among trials, development programs, funding and author overlap
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01 R03

N13 · Does the maintenance trial after a low-calorie diet use the same comparison as the initial one-year response question?

Current findings: The Wadden maintenance trial randomized 137 participants who had lost at least 5% through a low-calorie diet. Its selection conditions differ from the initial weight-loss response question.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The maintenance response is not transferred to a one-year 5% response among people first starting drug treatment.
Reason for missing information: The maintenance response is not transferred to a one-year 5% response among people first starting drug treatment.
Required materials and conditions: Weight-loss entry conditions, maintenance intervention, comparison and denominator
Materials to obtain first: The maintenance response is not transferred to a one-year 5% response among people first starting drug treatment.
Further research: Obtain original entry weight loss, maintenance definitions, selected participants, arm-specific denominators and counseling/intervention components.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Weight-loss entry conditions, maintenance intervention, comparison and denominator
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R04

N14 · Are the maintenance trial’s 24-week results and 52-week co-primary results separated?

Current findings: At 24 weeks, at least 5% maintenance was 73.9% versus 57.4% (P=0.033), with additional −2.4±0.8 kg versus +0.6±0.8 kg (P=0.010). Both 52-week co-primary results are recorded as showing no between-group difference.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Positive 24-week results are not repurposed as sustained superiority at 52 weeks. The statistical meaning of ±, 52-week effects, CIs, P values and arm-specific analysis denominators are absent from the summary.
Reason for missing information: Positive 24-week results are not repurposed as sustained superiority at 52 weeks. The statistical meaning of ±, 52-week effects, CIs, P values and arm-specific analysis denominators are absent from the summary.
Required materials and conditions: Time-specific original effects, co-primary endpoints, CIs and analysis hierarchy
Materials to obtain first: Positive 24-week results are not repurposed as sustained superiority at 52 weeks. The statistical meaning of ±, 52-week effects, CIs, P values and arm-specific analysis denominators are absent from the summary.
Further research: Obtain original estimates and CIs, missing-data handling and multiplicity plans for each co-primary endpoint and time point.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Time-specific original effects, co-primary endpoints, CIs and analysis hierarchy
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R04

N15 · Has weight loss avoided being extended to prevention of clinical cardiovascular events?

Current findings: The stored summary records weight as a surrogate for clinical events and states that MACE+ superiority was null.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The one-year 5% response is not converted to proof of cardiovascular prevention, survival benefit or cancer safety.
Reason for missing information: The one-year 5% response is not converted to proof of cardiovascular prevention, survival benefit or cancer safety.
Required materials and conditions: Separate direct results for the weight surrogate and clinical events
Materials to obtain first: The one-year 5% response is not converted to proof of cardiovascular prevention, survival benefit or cancer safety.
Further research: Link direct definitions, effects, CIs and follow-up for each clinical-event outcome as separate questions.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate direct results for the weight surrogate and clinical events
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N16 · Are MACE safety noninferiority, weight efficacy and cancer safety distinguished?

Current findings: MACE was 364 participants (6.1%) versus 369 (6.2%), HR 0.99 (95% CI 0.85~1.14), recorded as meeting the prespecified noninferiority margin of HR 1.40.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. These values are not weight-response effects or CIs and do not substitute for cancer safety.
Reason for missing information: These values are not weight-response effects or CIs and do not substitute for cancer safety.
Required materials and conditions: Original endpoint-specific prespecified margins, estimates, events and follow-up
Materials to obtain first: These values are not weight-response effects or CIs and do not substitute for cancer safety.
Further research: Link the MACE noninferiority plan and direct material for other harm endpoints separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original endpoint-specific prespecified margins, estimates, events and follow-up
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N17 · Has null MACE+ superiority avoided being converted to a null weight response?

Current findings: MACE+ is recorded as 707 participants (11.8%) versus 727 (12.1%), HR 0.97 (0.87~1.07), P=0.55.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Weight response and clinical-event effects are not mixed. No new CI level is attached to the MACE+ interval in this summary.
Reason for missing information: Weight response and clinical-event effects are not mixed. No new CI level is attached to the MACE+ interval in this summary.
Required materials and conditions: Events, estimates and tests for distinct efficacy endpoints
Materials to obtain first: Weight response and clinical-event effects are not mixed. No new CI level is attached to the MACE+ interval in this summary.
Further research: Link endpoint definitions, the prespecified superiority plan and the weight-response hierarchy using original material.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Events, estimates and tests for distinct efficacy endpoints
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01

N18 · Are manufacturer support, affiliated authors, design and manuscript roles separated?

Current findings: Full Eisai funding, company-affiliated authors, and sponsor participation in co-design and manuscript preparation are recorded. Funding and author overlap with BLOOM is also preserved.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Free product provision, outsourced analysis and each author’s detailed roles are not established by the summary. Company manuscript participation is not equated with outsourced analysis.
Reason for missing information: Free product provision, outsourced analysis and each author’s detailed roles are not established by the summary. Company manuscript participation is not equated with outsourced analysis.
Required materials and conditions: Separate records of cash funding, product provision, employee authors and external analysis roles
Materials to obtain first: Free product provision, outsourced analysis and each author’s detailed roles are not established by the summary. Company manuscript participation is not equated with outsourced analysis.
Further research: Obtain original disclosures of funding, products, affiliations, data access, analysis and manuscript roles separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate records of cash funding, product provision, employee authors and external analysis roles
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01 R03

N19 · Has the maintenance trial’s funding label avoided being converted to certification of a specific sponsor?

Current findings: The Wadden evidence-list funding entry is preserved only as “reported in the original text”.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. This ambiguous original label does not newly establish public funding, absence of corporate funding or independent replication.
Reason for missing information: This ambiguous original label does not newly establish public funding, absence of corporate funding or independent replication.
Required materials and conditions: Actual maintenance-trial funding, product, author and analysis records
Materials to obtain first: This ambiguous original label does not newly establish public funding, absence of corporate funding or independent replication.
Further research: Obtain the maintenance trial’s originally disclosed interests and research roles for each source.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Actual maintenance-trial funding, product, author and analysis records
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R04

N20 · Do the FDA cancer reanalysis and CAMELLIA efficacy report concern the same trial data?

Current findings: The 2020 FDA reanalysis is recorded as concerning the same 12,000 CAMELLIA participants. The FDA review paper and FDA safety communication are linked as separate report entries.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The reanalysis paper and regulatory document are not added as separate efficacy trials or new participant populations. Full-text content is not guessed.
Reason for missing information: The reanalysis paper and regulatory document are not added as separate efficacy trials or new participant populations. Full-text content is not guessed.
Required materials and conditions: Relationships among the original trial, completed reanalysis, regulatory documents and paper reports
Materials to obtain first: The reanalysis paper and regulatory document are not added as separate efficacy trials or new participant populations. Full-text content is not guessed.
Further research: Link completed reanalysis material and the result sources for each report.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Relationships among the original trial, completed reanalysis, regulatory documents and paper reports
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01 R02 R05

N21 · Are people diagnosed with cancer, primary cancers and patient-years preserved as different units?

Current findings: The FDA summary records 462 lorcaserin participants (7.7%, 520 primary cancers) versus 423 placebo participants (7.1%, 470 cancers), with approximately one additional cancer per 470 patient-years.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. People, tumors and patient-years are not added together, and no new risk difference, NNH or HR is calculated. Arm-specific patient-years are unverified.
Reason for missing information: People, tumors and patient-years are not added together, and no new risk difference, NNH or HR is calculated. Arm-specific patient-years are unverified.
Required materials and conditions: Original harm-event definitions, people, tumors, observation time and denominators
Materials to obtain first: People, tumors and patient-years are not added together, and no new risk difference, NNH or HR is calculated. Arm-specific patient-years are unverified.
Further research: Obtain original tables of cancer-event definitions, repeated primary cancers, exposure time and denominators.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original harm-event definitions, people, tumors, observation time and denominators
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R02 R05

N22 · Are cancer-signal timing, cancer types and statistical confirmation distinguished?

Current findings: The stored summary records a widening difference over time, with imbalances in pancreatic, colorectal and lung cancers contributing. It states that the public FDA communication did not supply an overall cancer risk ratio, CI or P value.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The regulatory decision is not converted to new statistical certification of overall cancer significance. Time-specific or cancer-type-specific values and CIs are not created.
Reason for missing information: The regulatory decision is not converted to new statistical certification of overall cancer significance. Time-specific or cancer-type-specific values and CIs are not created.
Required materials and conditions: Cancer-type and duration-specific effects, CIs, P values, plans and regulatory decisions
Materials to obtain first: The regulatory decision is not converted to new statistical certification of overall cancer significance. Time-specific or cancer-type-specific values and CIs are not created.
Further research: Link completed event tables, prespecified plans, duration-specific estimates and the basis for regulatory decisions separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Cancer-type and duration-specific effects, CIs, P values, plans and regulatory decisions
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R02 R05

N23 · Are a prespecified clinical cancer threshold and the weight-response threshold the same?

Current findings: The stored summary records no declared prespecified clinical cancer threshold. The 5% threshold is the selected weight-response definition.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The 5% response definition is not transferred to an acceptable cancer-risk or benefit–harm threshold. No new threshold is created.
Reason for missing information: The 5% response definition is not transferred to an acceptable cancer-risk or benefit–harm threshold. No new threshold is created.
Required materials and conditions: Prespecified importance and analysis plans for each efficacy and harm endpoint
Materials to obtain first: The 5% response definition is not transferred to an acceptable cancer-risk or benefit–harm threshold. No new threshold is created.
Further research: Preserve the plans and importance judgments for cancer and weight separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Prespecified importance and analysis plans for each efficacy and harm endpoint
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01 R05

N24 · Are the market-withdrawal record and efficacy grade preserved together?

Current findings: The preserved summary records the FDA request for voluntary withdrawal on February 13, 2020 and Eisai’s US market withdrawal, and explicitly states that weight grade C and 50 points do not mean that the drug is okay to take.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Current regulatory status was not newly looked up in this production. Efficacy benefit alone is not converted to availability or medication advice.
Reason for missing information: Current regulatory status was not newly looked up in this production. Efficacy benefit alone is not converted to availability or medication advice.
Required materials and conditions: Separate records of regulatory-event dates, scope, decisions and clinical efficacy
Materials to obtain first: Current regulatory status was not newly looked up in this production. Efficacy benefit alone is not converted to availability or medication advice.
Further research: If new regulatory material is supplied, link its original text, date and change event separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate records of regulatory-event dates, scope, decisions and clinical efficacy
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R05

N25 · Have withdrawal reasons for other serotonergic drugs avoided being repurposed?

Current findings: The stored summary explains that fenfluramine valvulopathy, sibutramine cardiovascular harms and rimonabant psychiatric harms differ from the reason for lorcaserin withdrawal.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Lorcaserin results are not extended to class-wide efficacy or cancer harms, and harms of other drugs are not used as lorcaserin values.
Reason for missing information: Lorcaserin results are not extended to class-wide efficacy or cancer harms, and harms of other drugs are not used as lorcaserin values.
Required materials and conditions: Direct distinctions among drug-specific efficacy, harms and regulatory events
Materials to obtain first: Lorcaserin results are not extended to class-wide efficacy or cancer harms, and harms of other drugs are not used as lorcaserin values.
Further research: If direct drug-specific material is supplied, link it with questions, participants and endpoints separated.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct distinctions among drug-specific efficacy, harms and regulatory events
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R05

N26 · Do gaps remain for other harms, discontinuation and long-term exposure?

Current findings: The parent safety status is Warning, and the preserved explanation focuses on cancer reanalysis and MACE.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Detailed tables of other adverse events, discontinuation and drug exposure were not newly checked and are not filled in as safe.
Reason for missing information: Detailed tables of other adverse events, discontinuation and drug exposure were not newly checked and are not filled in as safe.
Required materials and conditions: Arm-specific material on all harms, serious events, discontinuation reasons and exposure denominators
Materials to obtain first: Detailed tables of other adverse events, discontinuation and drug exposure were not newly checked and are not filled in as safe.
Further research: Original safety collection, arm-specific events, discontinuation, exposure and long-term material are needed.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Arm-specific material on all harms, serious events, discontinuation reasons and exposure denominators
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01 R02 R05

N27 · Are the scope of safety reanalysis and independent harm replication distinguished?

Current findings: The stored summary explicitly states that the FDA reanalysis is a safety review of the same CAMELLIA trial and is not counted as a separate efficacy trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. Other harm replication or incidence material was not looked up, and independence was not established, in this production.
Reason for missing information: Other harm replication or incidence material was not looked up, and independence was not established, in this production.
Required materials and conditions: Relationships between reanalysis of the same trial and independent external harm material
Materials to obtain first: Other harm replication or incidence material was not looked up, and independence was not established, in this production.
Further research: If external harm material is supplied, link trial, exposure, population and denominator relationships separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Relationships between reanalysis of the same trial and independent external harm material
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01 R02 R05

N28 · Are citation URLs, no-abstract labels and unread full text distinguished?

Current findings: Five citation URLs are linked as preserved in the source. The original flag for FDA review paper PMID 32905671 is “no abstract; do not guess content”. All external sources remain unread in this production.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. A URL is not promoted to acquisition of an abstract or full text; content from another document is not transferred and marked as a reading of the FDA paper.
Reason for missing information: A URL is not promoted to acquisition of an abstract or full text; content from another document is not transferred and marked as a reading of the FDA paper.
Required materials and conditions: Separate actual-access records for papers, regulatory documents and stored summaries
Materials to obtain first: A URL is not promoted to acquisition of an abstract or full text; content from another document is not transferred and marked as a reading of the FDA paper.
Further research: Link originals obtained by the user for each source and record actual access status.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate actual-access records for papers, regulatory documents and stored summaries
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01 R02 R03 R04 R05

N29 · Are registration identifiers and reading of registrations, protocols and SAPs separated?

Current findings: The CAMELLIA and FDA reanalysis evidence-list identifiers are both NCT02019264. The original registration-identifier values for BLOOM and the maintenance trial are “not applicable”.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No registration URL is in the source, so no new URL is invented and marked as accessed. “Not applicable” is not converted to new certification that no registration exists.
Reason for missing information: No registration URL is in the source, so no new URL is invented and marked as accessed. “Not applicable” is not converted to new certification that no registration exists.
Required materials and conditions: Directly preserved registration, protocol and SAP material for each trial
Materials to obtain first: No registration URL is in the source, so no new URL is invented and marked as accessed. “Not applicable” is not converted to new certification that no registration exists.
Further research: If original registrations, protocols and SAPs are supplied, link them to each trial.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Directly preserved registration, protocol and SAP material for each trial
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01 R02 R03 R04

N30 · Are the reference date, corrections, Korean and English manuscripts and parent axes preserved in their original form?

Current findings: The full stored-summary copy preserves the reference date 2026-08-26, empty correction history, Korean and English manuscripts, parent grade C, 50 points, Warning and original assessment axes.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The production date is not converted to a new clinical evidence date, and stored-summary cross-checking language is not used as completion of this review.
Reason for missing information: The production date is not converted to a new clinical evidence date, and stored-summary cross-checking language is not used as completion of this review.
Required materials and conditions: Original verdict, language-specific wording, reference date and correction history
Materials to obtain first: The production date is not converted to a new clinical evidence date, and stored-summary cross-checking language is not used as completion of this review.
Further research: If new material arises, link preservation of the original text and a separate update event to review of the existing content.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Original verdict, language-specific wording, reference date and correction history
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01 R02 R03 R04 R05

N31 · Has the selected response avoided being extended to all long-term weight loss, maintenance or clinical function?

Current findings: The stored summary records inconsistent long-term maintenance results and weight as a surrogate in the context of the parent grade C verdict.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. The one-year response is not converted to benefit across all durations, populations, weight-loss maintenance or clinical events. Medication or lifestyle-care instructions are not created.
Reason for missing information: The one-year response is not converted to benefit across all durations, populations, weight-loss maintenance or clinical events. Medication or lifestyle-care instructions are not created.
Required materials and conditions: Direct distinctions between selected participants, duration and response and long-term maintenance or clinical outcomes
Materials to obtain first: The one-year response is not converted to benefit across all durations, populations, weight-loss maintenance or clinical events. Medication or lifestyle-care instructions are not created.
Further research: Link participants, comparators, time points, effects and harms suited to each long-term question separately.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Direct distinctions between selected participants, duration and response and long-term maintenance or clinical outcomes
Why this condition is needed: Condition for recording direct comparisons, original values and interpretation boundaries for the selected question
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01 R03 R04

N32 · Are production completion, review of the existing content and independence certification separated?

Current findings: The current label is review of the existing content; active pending and completion flags for model/content/boundary are false. Original candidate-review pending and production-permitted labels are preserved as history.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Only the corresponding stored-summary information is recorded; detailed original material and the existing content remain to be reviewed. No new structural unit or independent clinical certification was created. Final unique-trial and participant totals are not recorded.
Reason for missing information: No new structural unit or independent clinical certification was created. Final unique-trial and participant totals are not recorded.
Required materials and conditions: Separate records of original candidate history, production status and review status
Materials to obtain first: No new structural unit or independent clinical certification was created. Final unique-trial and participant totals are not recorded.
Further research: Incorporate only the user’s subsequent material or decisions as separate events.
Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification.
Conditions for verification: Separate records of original candidate history, production status and review status
Why this condition is needed: Supplementary condition separating production status and scope of application
Application exceptions: Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.
Referenced methods: At least 5% weight loss at one year

Related sources R01 R02 R03 R04 R05