{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2959-s1", "verdict_number": "2959", "title": "Topiramate · Pediatric 24-week 50% headache-day response — Evidence Check", "view_version": "1.0", "view_created_date": "2026-10-12", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Migraine patients aged 8–17 at 31 US centers; detailed eligibility, baseline headaches and response-analysis denominators were unread.", "intervention": "Topiramate study drug; preserve the original identity of purchased generic drugs overencapsulated to match placebo.", "dose": "Actual dose, titration, dose reduction and administration schedules are absent from the preserved summary; only study identity is retained and no treatment instructions are created.", "comparator": "Shared placebo arm; direct comparison with the other active drug is a separate question.", "endpoint": "Proportion with at least a 50% reduction in headache days during the final 28 days of 24 weeks versus the baseline 28 days; distinguish this from mean headache days, attacks or intensity.", "duration": "24-week pediatric prevention comparison; retain the scope of planned futility stopping and incomplete follow-up.", "excluded_extensions": [ "No new research, effects, CIs, calculations, verdicts, independence certification, participant totals or medication/administration/treatment/drug-switching instructions are created." ] }, "requirements": [ { "item_id": "N01", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Selected drug: original question and subclaim verdict", "needed": "Each drug’s 50% headache-day response question, grade and note", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Each drug’s 50% headache-day response question, grade and note: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish the original subclaim verdict from this preparation and content review.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The selected original claim is increased 50% headache-day response with topiramate in children, graded D with the note of 55% versus 61% with placebo. The parent covers both drugs and is D with 30 points.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Subclaim score, status and axes are absent. Do not fill them from parent values or create a new verdict.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Selected subclaim and parent original verdict" }, { "item_id": "N02", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Selected placebo comparison", "needed": "Distinguish the selected drug, placebo and other active-drug comparisons", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Distinguish the selected drug, placebo and other active-drug comparisons: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Separate the selected placebo comparison from other active-drug and natural-history questions.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "This table concerns topiramate versus placebo. CHAMP also had an amitriptyline arm; distinguish that active-drug comparison from the selected placebo comparison.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not combine the two active-drug effects or equate placebo response with untreated natural history.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original three-arm comparisons and control conditions" }, { "item_id": "N03", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Actual pediatric population and application scope", "needed": "Age, diagnosis, baseline headaches, eligibility, exclusions and centers", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Age, diagnosis, baseline headaches, eligibility, exclusions and centers: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish the original age, diagnosis and period from application to other populations.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The parent outcome and advertising interpretation restrict the question to 24-week migraine prevention at ages 8–17. The trial was conducted at 31 US centers.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Detailed baseline headache days, diagnostic criteria, comorbidities and exclusions are unverified. Do not establish applicability to every pediatric age or to adults.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Pediatric eligibility, diagnosis and baseline-characteristic tables" }, { "item_id": "N04", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Actual drug exposure and dose information", "needed": "Product, study exposure, dose, titration and duration specifications", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Product, study exposure, dose, titration and duration specifications: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Separate study identity from unverified exposure details.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The selected intervention is topiramate. The preserved summary says generic drugs were purchased with grant funds and overencapsulated to match placebo.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Actual study dose, titration, dose reduction and administration schedules are absent from the summary. Do not create regimens, product recommendations or treatment instructions.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial drug, formulation, exposure specifications and actual-use records" }, { "item_id": "N05", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Placebo identity and masking scope", "needed": "Capsules, placebo composition, allocation and role-specific masking", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Capsules, placebo composition, allocation and role-specific masking: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish the masking label from actual implementation material.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "CHAMP is recorded as a multicenter double-blind placebo-controlled trial, with purchased generic drugs overencapsulated to match placebo.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "External original material on placebo ingredients and masking implementation, success or unmasking was unread.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Active/placebo specifications and role-specific masking records" }, { "item_id": "N06", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Randomization and three-arm denominators", "needed": "Allocation ratio, each arm, analysis and follow-up denominators", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Allocation ratio, each arm, analysis and follow-up denominators: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Display total and arm-specific randomization separately from response-analysis denominators.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "361 participants were randomized 2:2:1: amitriptyline 144, topiramate 145 and placebo 72. The selected drug’s original randomized denominator is 145.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not equate the total 361, other active arm or shared placebo arm with the selected response-analysis denominator. No new totals or participant counts are calculated.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific randomized, analyzed and followed-up flow" }, { "item_id": "N07", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Allocation concealment, baseline balance and measurement methods", "needed": "Random sequence, concealment, baseline and role-specific measurement", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Random sequence, concealment, baseline and role-specific measurement: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish design names from limitations in actual implementation material.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The preserved material describes a publicly funded double-blind randomized trial at 31 centers. Parent bias B2 is the original historical value.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Detailed external sequence, concealment, baseline-balance and assessor material was unread. A design name does not mean methods review is now complete.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation, concealment, baseline characteristics and assessment methods" }, { "item_id": "N08", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Concurrent care, rescue medication, drug changes and adherence", "needed": "Arm-specific accompanying exposure, rescue, adherence and change handling", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Arm-specific accompanying exposure, rescue, adherence and change handling: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish assignment effects from actual-use and concurrent-care limitations.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The current summary identifies the selected preventive drug, placebo and 24-week comparison.", "condition_status": "Unverified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Detailed concurrent treatment, rescue medication, adherence, departures and changes are absent. Do not certify separation of the selected drug’s contribution from other changes or create drug-switching instructions.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific accompanying exposure, rescue, adherence and change tables" }, { "item_id": "N09", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Original 50% headache-day response definition and period", "needed": "Baseline/final periods, response threshold and headache-day definition", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Baseline/final periods, response threshold and headache-day definition: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish threshold response from mean change and other symptom measures.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The primary endpoint was the proportion with at least a 50% reduction in headache days during the final 28 days of 24 weeks compared with the baseline 28 days.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not turn this into mean headache-day reduction, pain intensity, headache cure or a 50% reduction in attacks. Detailed response recording methods were unread.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original headache-day, response, baseline and assessment-window definitions" }, { "item_id": "N10", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Headache-day collection, recording and missing-data handling", "needed": "Headache recording, measurement, omissions, assessment masking and response classification", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Headache recording, measurement, omissions, assessment masking and response classification: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish people from recording days, repeated measurements and adjudication denominators.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The preserved material provides the proportional endpoint based on baseline and final 28-day headache records.", "condition_status": "Unverified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Recording tools, recorded-day counts, omitted days, incomplete diaries and response adjudication procedures were unread. People, days and repeated measurements are not counted as new participants.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original headache recording, omissions and response classification" }, { "item_id": "N11", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Selected-arm and placebo responder percentages", "needed": "Original selected/placebo response proportions, denominators and aggregation", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Original selected/placebo response proportions, denominators and aggregation: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Show original selected percentages together with gaps in analysis denominators and event counts.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The topiramate responder rate was 55% and placebo 61%. The original text says both active-drug responder percentages were numerically lower than placebo.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not calculate responder event counts from rounded percentages and randomized denominators. Do not add the same 72 placebo participants as new people across two tables.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific responder counts, denominators and original response tables" }, { "item_id": "N12", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Selected drug’s OR, interval and P value", "needed": "Effect measure, original interval and test for the selected placebo comparison", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Effect measure, original interval and test for the selected placebo comparison: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Separate selected-drug estimates from other active-drug and review estimates.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "Topiramate versus placebo is preserved as OR 0.81, interval 0.39–1.68 and P=0.48.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not copy the other drug’s OR, interval or P value or calculate new absolute differences, RR, NNT or CIs.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original effect, interval and P-value tables for each comparison" }, { "item_id": "N13", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Interval level and multiplicity across three comparisons", "needed": "Original interval levels, three pairwise tests and adjustment plan", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Original interval levels, three pairwise tests and adjustment plan: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Preserve interval labels and the multiple-comparison plan separately.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The three pairwise comparisons used Bonferroni-adjusted two-sided alpha 0.017. The original summary explicitly labels the amitriptyline interval as 98.3% CI and records the topiramate interval as 0.39–1.68.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not arbitrarily relabel intervals as 95%. The individual original-table interval-level label for topiramate was unread, and no new adjustment calculations are performed.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Three pairwise analyses, original intervals and adjustment-plan material" }, { "item_id": "N14", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Numerical percentages versus superiority or equivalence", "needed": "Original proportions, comparative effects, intervals and interpretation", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Original proportions, comparative effects, intervals and interpretation: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish numerical ordering from comparative testing, equivalence and precision.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The preserved original text says neither active drug exceeded placebo and their responder percentages were numerically lower.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Original percentages alone do not certify statistically significant placebo superiority, zero drug effect, equivalence or exclusion of every meaningful benefit.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original comparisons, clinical importance and interpretation criteria" }, { "item_id": "N15", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Response estimand and actual analysis population", "needed": "Assignment/actual-use effects, analysis populations, missing data and adjustment models", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Assignment/actual-use effects, analysis populations, missing data and adjustment models: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish randomized, actual-use and completer effects and analysis denominators.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The preserved evidence provides 361 randomized participants and arm-specific responder percentages and ORs.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Exact arm-specific response-analysis denominators, ITT/PP, missing-data handling and covariates are absent. Do not substitute randomized counts for completed-response denominators.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original response-analysis populations, models and missing-data handling" }, { "item_id": "N16", "question_type": "Comparative efficacy · Pediatric drug response", "question": "24-week completion and incomplete-follow-up limitations", "needed": "Arm-specific completion, discontinuation, withdrawal reasons and handling", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Arm-specific completion, discontinuation, withdrawal reasons and handling: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Present completion separately from response, observation and analysis denominators.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "Selected topiramate’s 24-week completion is recorded as 78%. The parent rationale describes 20–22% incomplete follow-up across the two active drugs.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not turn completion into response rate or a response-analysis denominator. Placebo completion, arm-specific withdrawal reasons and missing-data sensitivity are absent.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific completion, withdrawals, reasons and sensitivity analyses" }, { "item_id": "N17", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Selected drug’s prespecified futility-interim values", "needed": "Interim analysis, conditional power and prespecified futility threshold", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Interim analysis, conditional power and prespecified futility threshold: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish planned futility values from actual response effects.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The original study records amitriptyline 16% and topiramate 14% conditional power below the prespecified 20% futility threshold. The selected topiramate value is 14%.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not turn conditional power into current efficacy probability, responder percentage, confidence or participant proportion. No new power calculations are performed.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Interim-analysis plan, conditional power and stopping records" }, { "item_id": "N18", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Early stopping decision and statistical-boundary names", "needed": "DSMB recommendation, NINDS approval, stopping time and original boundary", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "DSMB recommendation, NINDS approval, stopping time and original boundary: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Connect prespecified stopping rules with actual stopping and incomplete-follow-up limitations.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The trial stopped at the prespecified futility threshold after DSMB recommendation and NINDS approval. The original text says no separate name was given to the stopping boundary.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not invent a statistical-boundary name, exact stopping date or full follow-up impact. Early stopping is not counted as independent repeated null evidence.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Stopping decisions, interim-analysis plan and follow-up records" }, { "item_id": "N19", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Prespecified clinical threshold and exclusion of meaningful benefit", "needed": "Prespecified response-benefit threshold, intervals and clinical importance", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Prespecified response-benefit threshold, intervals and clinical importance: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish null results from the range of benefit that can be excluded.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The original rationale says no prespecified clinical threshold allowed exclusion of meaningful benefit, and the counterpoint says wide intervals leave benefit possible.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not invent an MCID, passing threshold, noninferiority or exclusion of all benefit to enlarge the null finding.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified importance, interval interpretation and comparison criteria" }, { "item_id": "N20", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Registration, protocol, SAP and prespecified plans actually read", "needed": "Original registration, endpoints, interim analyses and amendment history", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Original registration, endpoints, interim analyses and amendment history: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish preserved plan narratives from actual external-original reading.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "CHAMP’s registration identifier is NCT01581281. The preserved summary describes the primary endpoint, multiple comparisons and planned interim analysis.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Original registration, exact dates, protocol, SAP and amendment history were unread in this conversion. An identifier or citation does not mean prospective-planning review is complete.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "NCT01581281 registration, protocol, SAP and amendments" }, { "item_id": "N21", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Direct comparison between the two active drugs", "needed": "Original active-drug comparative effects, intervals and question", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Original active-drug comparative effects, intervals and question: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Display placebo comparisons separately from direct active-drug comparisons.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The original material records three pairwise comparisons, but presents each drug’s placebo comparison as the selected effect.", "condition_status": "Unverified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not derive direct superiority or equivalence between the drugs from 52% and 55% or separate placebo ORs. Do not create drug-switching guidance.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original active-drug comparison and interval tables" }, { "item_id": "N22", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Extension to adults, other preventives or other clinical endpoints", "needed": "Direct evidence by age, indication, ingredient, function and clinical outcome", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Direct evidence by age, indication, ingredient, function and clinical outcome: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish the selected pediatric response from other populations and outcomes.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The original advertising interpretation says adult migraine evidence cannot be transferred to ages 8–17 and restricts the claim to these two drugs and 24-week prevention.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not create conclusions of null efficacy for all pediatric preventives or adult indications, or new quality-of-life, function or treatment-replacement conclusions.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual direct material by population, ingredient and endpoint" }, { "item_id": "N23", "question_type": "Comparative efficacy · Pediatric drug response", "question": "One CHAMP report, sibling tables and shared placebo", "needed": "Link the same trial, three arms, registration, bibliography and participants", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Link the same trial, three arms, registration, bibliography and participants: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish comparison questions from the same trial, shared control and participant units.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The two tables share the same CHAMP report, registration, 72 placebo participants and 2959 preserved summary. Separating the drug questions does not create a new trial.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not newly sum papers, registration, three arms, two tables or 28-day windows as independent trials or participants. Confirmed trial/participant totals remain unrecorded.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "CHAMP report, registration and arm-specific linkage material" }, { "item_id": "N24", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Scope of linking the topiramate review to the selected drug", "needed": "Review populations, ingredient, endpoint, duration, included trials and selected applicability", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Review populations, ingredient, endpoint, duration, included trials and selected applicability: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish topiramate-review context from the selected direct placebo trial.", "current_reports": [ "R01", "R02" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "Le 2017 is recorded as a topiramate review of at least 50% reduction in headache frequency, with 4 RCTs and 465 participants. It is review context for topiramate’s 50% response; CHAMP inclusion, overlap, endpoint correspondence and unique-trial totals are unverified.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not certify the review’s 4 trials/465 participants as current unique totals or add them to CHAMP’s 361. Inclusion, overlap and exact measurement windows were externally unread.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review included-trial, population, endpoint, duration and overlap tables" }, { "item_id": "N25", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Original effect in the topiramate meta-analysis", "needed": "Review response definitions, effect measure, interval, test and inclusion context", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Review response definitions, effect measure, interval, test and inclusion context: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Separate the original RR from the direct trial’s OR, period and endpoint.", "current_reports": [ "R02" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The Le 2017 review records a null result for at least 50% headache-frequency reduction: RR 1.26, 95% CI 0.94–1.67 and P=0.12.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not combine the review RR with CHAMP OR 0.81 or certify identical 28-day headache-day definitions and 24-week periods across all included trials. Wide null-result intervals do not establish zero effect or equivalence.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review effect tables, included trials, definitions and analysis material" }, { "item_id": "N26", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Repeated null findings across the two drugs", "needed": "Drug-specific direct evidence, independent replication and unique-trial linkage", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Drug-specific direct evidence, independent replication and unique-trial linkage: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Preserve drug-specific evidence scope and differences in replication.", "current_reports": [ "R01", "R02" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The original counterview says direct placebo evidence for amitriptyline is mainly the single CHAMP trial; topiramate meta-analyses concern that ingredient’s context.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not elevate the paired drugs to repeated refutation or expand to all pediatric preventives. Retain unverified same-cohort/review overlap and independence.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Drug-specific direct reports and included-trial linkage material" }, { "item_id": "N27", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Public grants, drug purchases and product support", "needed": "Funding, generic purchases, pharmaceutical support and contracts", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Funding, generic purchases, pharmaceutical support and contracts: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish publicly funded purchases from pharmaceutical support and unverified roles.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "CHAMP had NIH/NINDS and NCATS public grants; generic drugs were purchased and capsules matched using grant funds. The Korean product record states no pharmaceutical donation, analysis service or cofunding, while the English record says these were not reported.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not turn generic purchases into donated company products; preserve both original language versions. Full support/involvement disclosures were unread.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding, purchases, products and company-relationship disclosures" }, { "item_id": "N28", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Authors, analysis, medical writing, publication costs and data rights", "needed": "Author affiliations, company relationships and analysis/writing/publication roles", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Author affiliations, company relationships and analysis/writing/publication roles: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Display known funding separately from unverified roles.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The preserved summary provides public funding and some pharmaceutical-support items.", "condition_status": "Unverified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Full employee-author, consultancy, medical-writing, publication-cost and data-control disclosures are absent. Nonmention does not establish absence of all roles or independent clinical certification.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Author/supporter roles, COI and data/publication rights" }, { "item_id": "N29", "question_type": "Supplementary harm evidence", "question": "Selected drug’s common harms", "needed": "Selected/placebo event definitions, collection, frequency and denominators", "role": "Supplementary", "role_reason": "A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Selected/placebo event definitions, collection, frequency and denominators: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Separate drug-specific common events from placebo comparisons and collection gaps.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The safety summary says paresthesia and weight loss were more common with topiramate.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not copy other active-drug harms to the selected drug. Original event counts, arm-specific rates, intervals and collection methods are absent and are not invented.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific full harm, denominator and event-definition tables" }, { "item_id": "N30", "question_type": "Supplementary harm evidence", "question": "Selected drug’s treatment-related serious events", "needed": "Serious events, relatedness adjudication, people/events and exposure denominators", "role": "Supplementary", "role_reason": "A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Serious events, relatedness adjudication, people/events and exposure denominators: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Distinguish original reported relatedness from limits in direct causality and person counts.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The original safety sentence records 1 suicide-attempt event in the topiramate arm as an adjudicated treatment-related serious event.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not sum events into unique people or incidence or certify causal risk at every age. Detailed adjudication, exposure and event course were unread; no medication/treatment instructions are created.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original serious-event tables, relatedness adjudication, exposure and event-course material" }, { "item_id": "N31", "question_type": "Supplementary harm evidence", "question": "24-week harms versus long-term and rare-event safety", "needed": "Long-term exposure, follow-up, withdrawal, rare events and population-specific material", "role": "Supplementary", "role_reason": "A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Long-term exposure, follow-up, withdrawal, rare events and population-specific material: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Separate efficacy comparisons from long-term/rare-harm gaps.", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The current pediatric comparison is 24 weeks with early stopping and incomplete follow-up. The parent safety warning is original verdict context.", "condition_status": "Unverified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Do not fill in absence of long-term/rare harms, safety for all children or equivalent harms between drugs. Do not merge harms into null efficacy or treatment-replacement instructions.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term harms, exposure, discontinuation and follow-up material" }, { "item_id": "N32", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Actual summary reading and unread external materials", "needed": "Status of two bibliographic records, stored summary, abstracts, full texts, registration and plans", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Status of two bibliographic records, stored summary, abstracts, full texts, registration and plans: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Display summary reading separately from unread external materials.", "current_reports": [ "R01", "R02" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "The entire 2959 preserved summary was read. CHAMP and Le-review PubMed URLs are linked as in the original bibliography.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "External abstracts, full texts, registration, protocol and SAP were unread; external link, click and screen checks were not performed. A URL does not mean external reading or completed content review.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original trial paper, review, registration, protocol and SAP" }, { "item_id": "N33", "question_type": "Comparative efficacy · Pediatric drug response", "question": "Original history, verdict linkage, preparation and content review", "needed": "Subclaim/parent Korean-English text, axes, dates, corrections, existing selection and condition preservation/application", "role": "Required", "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.", "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.", "criterion": "Subclaim/parent Korean-English text, axes, dates, corrections, existing selection and condition preservation/application: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.", "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.", "condition_origin": "Chamgap-specific application condition; review of existing content incomplete", "proposed_research": "Record original verdicts/corrections separately from preparation and content review.", "current_reports": [ "R01", "R02" ], "existence": "Relevant original wording, bibliography and context appear in the stored review summary; detailed external material is unverified.", "acquired_read": "Summary read; related external material unread", "observation": "Original Korean/English text, axes, 2026-08-26 cut-off, empty corrections/deliberation and selected subclaim are preserved as a complete copy. Original candidate pending/eligibility labels are selection history.", "condition_status": "Partly verified", "status_reason": "Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.", "missingness": "Keep absent subclaim score, status and axes; do not use the evidence cut-off as the current review date. Existing content review is incomplete, completion is false, no new unit is created and final independent totals remain unrecorded.", "uncertainty": "External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original summary, existing selection and condition-preservation/application production events" } ], "reports": [ { "report_id": "R01", "title": "Powers SW, et al. Trial of Amitriptyline, Topiramate, and Placebo for Pediatric Migraine. N Engl J Med. 2017;376:115-124. PMID: 27788026.", "url": "https://pubmed.ncbi.nlm.nih.gov/27788026/", "report_type": "Stored bibliographic summary of a multicenter three-arm trial", "existence": "Present in actual bibliography, evidence entries and relevant wording of the stored summary", "acquired_read": "Summary read; external abstracts, full texts, registration and plans unread", "independent_replication": "The same CHAMP report; do not sum the two drug comparisons as independent replication.", "observed_result": "Topiramate 55% versus placebo 61%; OR 0.81 (interval 0.39–1.68), P=0.48. Original values for the other active drug have a separate scope.", "result_level": "Selected-drug OR, interval, P value and responder percentages; preserve the complete original two-drug wording of the parent evidence entry.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Summary read", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts." }, { "material_type": "External abstract", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts." }, { "material_type": "External full text", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts." }, { "material_type": "Original registration", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts." }, { "material_type": "Protocol/SAP", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/27788026/" } ] }, { "report_id": "R02", "title": "Le K, et al. Is topiramate effective for migraine prevention in patients less than 18 years of age? J Headache Pain. 2017;18:69. 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Sample size alone does not determine precision.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "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" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The same CHAMP trial’s three arms, two drugs, shared placebo, registration and sibling tables: distinguish selected comparisons without adding unique trials or participants. The topiramate 50% response review provides context; CHAMP inclusion, overlap, endpoint correspondence and unique-trial totals are unverified. CHAMP inclusion in the review, overlap among trials and actual independence remain unverified." }, "history": [ { "date": "2026-10-12", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public reader views and materials were prepared from the existing 33 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-12" }