# Lorcaserin × At least 5% weight loss at one year — Evidence sheet separating response, maintenance and cancer reanalysis Verdict 2950 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-11 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - 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 ## Checklist items ### N01 · Are the selected one-year 5% response and the parent long-term weight verdict distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The CAMELLIA citation identifies participants with overweight or obesity, and the stored summary records 12,000 randomized participants. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: CAMELLIA allocated 12,000 participants in groups of 6,000, with median follow-up of 3.3 years. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: CAMELLIA records at least 5% weight loss at one year as 38.7% versus 17.4%, P<0.001. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: CAMELLIA is designed as a randomized cardiovascular noninferiority trial; the stored summary records MACE safety and MACE+ efficacy as primary endpoints. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: At least 5% weight loss at one year - Related sources: R01 ### N08 · Are randomization, blinding and outcome-analysis procedures preserved? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The source explicitly describes CAMELLIA as a multicenter, double-blind, placebo-controlled randomized trial. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Unverified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: BLOOM one-year retention is 55.4% (883/1595) versus 45.1% (716/1587). - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The stored summary records weight as a surrogate for clinical events and states that MACE+ superiority was null. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: At least 5% weight loss at one year - Related sources: R01 ### N16 · Are MACE safety noninferiority, weight efficacy and cancer safety distinguished? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: MACE+ is recorded as 707 participants (11.8%) versus 727 (12.1%), HR 0.97 (0.87~1.07), P=0.55. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: At least 5% weight loss at one year - Related sources: R01 ### N18 · Are manufacturer support, affiliated authors, design and manuscript roles separated? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The Wadden evidence-list funding entry is preserved only as “reported in the original text”. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The stored summary records no declared prespecified clinical cancer threshold. The 5% threshold is the selected weight-response definition. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: At least 5% weight loss at one year - Related sources: R05 ### N25 · Have withdrawal reasons for other serotonergic drugs avoided being repurposed? Verification status: Partly verified Reading scope: Summary read; external materials not read - Current findings: The stored summary explains that fenfluramine valvulopathy, sibutramine cardiovascular harms and rimonabant psychiatric harms differ from the reason for lorcaserin withdrawal. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Unverified Reading scope: Summary read; external materials not read - Current findings: The parent safety status is Warning, and the preserved explanation focuses on cancer reanalysis and MACE. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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”. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - 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? Verification status: Partly verified Reading scope: Summary read; external materials not read - 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. - 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. - 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. - Remaining uncertainty: Unread or unverified materials do not mean zero effect, zero events, safety or new clinical certification. - Referenced methods: At least 5% weight loss at one year - Related sources: R01, R02, R03, R04, R05 ## Evidence and sources ### 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](https://pubmed.ncbi.nlm.nih.gov/30145941/) Materials actually read: Summary read; external materials not read Findings recorded in the 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 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. | 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](https://pubmed.ncbi.nlm.nih.gov/32905671/) Materials actually read: Summary read; external materials not read Findings recorded in the 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 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. | 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](https://pubmed.ncbi.nlm.nih.gov/20647200/) Materials actually read: Summary read; external materials not read Findings recorded in the 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 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. | 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](https://pubmed.ncbi.nlm.nih.gov/29288545/) Materials actually read: Summary read; external materials not read Findings recorded in the 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 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. | 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](https://www.fda.gov/media/135189/download) Materials actually read: Summary read; external materials not read Findings recorded in the 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 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. | 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 | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 1.0. Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed.