{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2962-s1", "verdict_number": "2962", "title": "High-dose green tea extract · Evidence Check for increased liver failure or death", "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": "MGTT safety analysis: 1,021 postmenopausal women aged 50-70 with normal baseline enzymes (513/508); direct clinical liver-failure/death event denominators unverified", "intervention": "High-dose green tea extract research capsules", "dose": "Original research exposure: about 843 mg EGCG daily for 12 months; other doses/formulations are separate context, not intake, withdrawal or rechallenge instructions", "comparator": "Placebo; direct clinical-event definitions, collection, denominators and effect details unverified", "endpoint": "Increased clinical liver failure or death; distinguished from CTCAE liver-function abnormalities, ALT/AST changes and severe enzyme grades", "duration": "Original study: 12 months; actual direct-event follow-up, long-term outcomes and exposure-time denominators unverified", "excluded_extensions": [ "No new clinical evidence, effects, confidence intervals, grades, independence certification, event sums or product-intake/monitoring/interruption/rechallenge/treatment instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "What are the original clinical-event question and subclaim verdict?", "needed": "Actual text, grade and note of the increased liver failure/death subclaim", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Actual text, grade and note of the increased liver failure/death subclaim; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish the original verdict from current preparation and user-review events", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The selected subclaim is increased liver failure or death, originally graded ?, with the note that the trial did not establish these outcomes.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "The selected record has no score, status or axes. Parent D, 34 points, Warning and axes are not used to fill a subclaim score or a new clinical-event verdict.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original selected subclaim and parent verdict" }, { "item_id": "N02", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are the parent liver-enzyme safety question and selected clinical events distinguished?", "needed": "Distinguish parent claim/analysis endpoints from direct liver-failure/death evidence", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Distinguish parent claim/analysis endpoints from direct liver-failure/death evidence; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Display biochemical harm and direct clinical events as separate questions", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The parent effect is no liver burden; its verdict concerns enzyme harm from high-dose capsules. Its counterpoint and product facts state that increased liver failure/death was not established.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Significant enzyme abnormalities are not reused as directly observed effects on clinical liver failure/death.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions/results for enzyme endpoints and clinical events" }, { "item_id": "N03", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are the clinical liver-failure definition and assessment pathway provided?", "needed": "Clinical liver-failure diagnosis, severity, confirmation and prespecified event definition", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Clinical liver-failure diagnosis, severity, confirmation and prespecified event definition; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Present actual clinical liver-failure confirmation criteria and collection pathways", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The original material records that increased clinical liver failure was not established. The evidence endpoint is CTCAE grade 2-or-higher liver-function abnormality.", "condition_status": "Unverified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Clinical diagnostic criteria, independent assessment, admission, organ-function and prespecified plans are absent from the summary. CTCAE enzyme grades do not substitute for clinical liver failure.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Liver-failure event definitions, assessment materials and plans" }, { "item_id": "N04", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are death causes, types and confirmation methods provided?", "needed": "All-cause death, liver-related death, cause confirmation and event definitions", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "All-cause death, liver-related death, cause confirmation and event definitions; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish direct liver-failure, all-cause death and liver-related death materials", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The selected original wording is increased liver failure or death; the parent summary says increased death was not established.", "condition_status": "Unverified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "The scope of all-cause/liver-related deaths, cause assessment and official confirmation is absent from the summary. The two clinical events are not combined as the same event.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Death definitions, cause assessments and follow-up materials" }, { "item_id": "N05", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are actual liver-failure events, group denominators and follow-up available?", "needed": "Liver-failure events, confirmation, observation and withdrawal denominators by group", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Liver-failure events, confirmation, observation and withdrawal denominators by group; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Present direct events together with actual observed denominators", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The summary read only states that increased clinical liver failure was not established.", "condition_status": "Unverified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Liver-failure events, group clinical-event denominators and loss to follow-up are not provided. This is not converted into absence, zero events or no risk, or filled with enzyme events.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original liver-failure events, group analyses and follow-up tables" }, { "item_id": "N06", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are direct death events, denominators, effects and intervals available?", "needed": "Deaths, person/time denominators, comparative effects and uncertainty", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Deaths, person/time denominators, comparative effects and uncertainty; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Present original mortality-comparison values and gaps separately", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The original boundary that increased death was not established is retained.", "condition_status": "Unverified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Death events, RR/OR/HR, confidence intervals and time denominators are absent from the summary. Parent OR 7.0 is not copied as a mortality effect; no new effects are calculated.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original group death events, denominators and direct effects" }, { "item_id": "N07", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Is missing direct-event collection distinguished from a null-effect test?", "needed": "Actual collection, reporting, analysis scope and original interpretation", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Actual collection, reporting, analysis scope and original interpretation; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish non-establishment/unverified information from actual null-effect tests", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The original subclaim note says the trial did not establish liver failure/death.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Absent details of direct-event collection/testing are not turned into a statistically null mortality trial or proof of equivalence.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinical-event collection/analysis specifications and original results" }, { "item_id": "N08", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "What were the actual analysis-population eligibility and baseline enzymes?", "needed": "Age, sex, baseline condition, eligibility and exclusion criteria", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Age, sex, baseline condition, eligibility and exclusion criteria; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish applicability to normal-baseline participants from other clinical populations", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "MGTT’s safety analysis followed 1,021 postmenopausal women aged 50-70 with normal baseline enzymes, 513/508, for 12 months.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "This is not generalized as direct risk data for every sex/age, liver disease or abnormal baseline enzymes. Detailed eligibility remains unread.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original safety-analysis eligibility, baseline characteristics and exclusion tables" }, { "item_id": "N09", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are safety-analysis denominators distinguished from original assignment/exclusions?", "needed": "Flow from assignment through baseline, initial testing and safety analysis", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Flow from assignment through baseline, initial testing and safety analysis; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Present baseline, early withdrawal, observation and analysis denominators separately", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The stored summary records 1,021 safety-analysis participants and prespecified exclusions of three missing baseline values and 51 withdrawing before the first monthly test.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "1,021 is not relabeled as the total randomized population; exclusions are not added to calculate a new total. Clinical-event analysis denominators remain separately unverified.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original assignment, safety-analysis and clinical-event flow tables" }, { "item_id": "N10", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "What were the actual research exposure and duration of high-dose capsules?", "needed": "Original EGCG, capsules, actual research exposure, interruption and duration specifications", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Original EGCG, capsules, actual research exposure, interruption and duration specifications; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish research identity from actual exposure and clinical-event follow-up", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The parent ingredient identifies research with high-dose green tea extract capsules providing about 843 mg EGCG daily for 12 months.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "No new intake, product-use or treatment instructions are created. Assigned versus actual exposure, interruption and clinical-event timing details are unverified.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial capsule, exposure/adherence/interruption and event-timing materials" }, { "item_id": "N11", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are placebo/product composition and concurrent exposures verified?", "needed": "Active/placebo composition, matching, caffeine, concurrent exposure and baseline differences", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Active/placebo composition, matching, caffeine, concurrent exposure and baseline differences; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish selected exposure from other possible causes and comparison conditions", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The stored evidence is a prespecified safety analysis of a double-blind placebo-controlled randomized trial.", "condition_status": "Unverified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Placebo composition, caffeine exposure, concurrent medication, alcohol, infection and baseline risks are absent from the summary. A caffeine tag is not converted into actual product content.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product/placebo specifications, concurrent exposures and baseline tables" }, { "item_id": "N12", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Do at least 800 mg/four months and lower-dose contexts answer the same direct question?", "needed": "Original other-dose/duration/population materials and direct clinical events", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Original other-dose/duration/population materials and direct clinical events; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish dose/duration/population enzyme signals from gaps in direct clinical events", "current_reports": [ "R01", "R02" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The preserved EFSA context describes ALT/AST elevation in some participants exposed to at least 800 mg EGCG from extracts for at least four months. The same signal was not verified at 316 mg daily or less.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "This is not converted into direct liver-failure/death effects, a safe dose or lower-dose recommendation. Effects of other exposures are not added together.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "EFSA materials included by exposure/duration and clinical endpoint" }, { "item_id": "N13", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are traditional brewed green tea and concentrated capsules distinguished?", "needed": "Direct evidence by exposure form, composition and duration", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Direct evidence by exposure form, composition and duration; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Record formulation-specific applicability separately", "current_reports": [ "R01", "R02" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The original account explicitly distinguishes traditional brewed green tea from concentrated capsule exposures.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "High-dose capsule enzyme signals are not reused as clinical liver failure/death for every beverage/formulation/exposure, nor as safety certification of other formulations.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original exposure-form and direct clinical-endpoint materials" }, { "item_id": "N14", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "What is the current evidence scope for randomization and masking?", "needed": "Randomization, concealment, role-specific masking and actual outcomes measured", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Randomization, concealment, role-specific masking and actual outcomes measured; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish enzyme-analysis methods from direct clinical-event assessment", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The original account describes IDS-pharmacy computer-generated block randomization and double masking of staff, participants, laboratory personnel and endpoint assessors.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Preserved quotations and parent B0 are not current completed method verification. Separate liver-failure/death assessment processes remain unread.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original randomization, masking and clinical-event assessment methods" }, { "item_id": "N15", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are the original efficacy primary endpoint and prespecified safety analysis distinguished?", "needed": "Planned hierarchy of breast density, safety, liver failure and death", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Planned hierarchy of breast density, safety, liver failure and death; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish planned efficacy, enzyme harm and clinical-event hierarchies", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The original MGTT efficacy primary endpoint was breast density; the parent verdict concerns a prespecified CTCAE grade 2-or-higher liver-function safety analysis.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Prespecified enzyme safety is not converted into a prespecified liver-failure/death primary-endpoint plan.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol, safety plan and direct clinical-event lists" }, { "item_id": "N16", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are registration identifiers distinguished from actually read plans?", "needed": "NCT00917735, registration history, protocol, SAP and event plans", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "NCT00917735, registration history, protocol, SAP and event plans; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish preserved identifiers from external reading and direct-event plans", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The stored summary describes NCT00917735 and correspondence with the prespecified safety analysis.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Registration dates/text, changes and liver-failure/death plans remain unread in this run. Identifier existence is not new certification of prespecification.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration, protocol, SAP and clinical-event plans" }, { "item_id": "N17", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Do CTCAE grades differ from clinical liver-failure diagnoses?", "needed": "Definitions of biochemical liver-function grades and clinical disease", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Definitions of biochemical liver-function grades and clinical disease; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Separate test-abnormality severity from clinical-event diagnosis", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The evidence endpoint is CTCAE grade 2-or-higher liver-function abnormality. The parent explicitly distinguishes enzyme harm from non-establishment of clinical liver failure/death.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "One CTCAE grade 4 case is not converted into one clinical liver-failure case or one death.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "CTCAE classifications, test values and clinical-diagnosis assessments" }, { "item_id": "N18", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Was the parent moderate-or-worse liver-function effect reused?", "needed": "Distinguish original enzyme-harm events/denominators/effects from direct endpoints", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Distinguish original enzyme-harm events/denominators/effects from direct endpoints; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Present parent harm effects and selected clinical-event effects separately", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The parent reports 26 extract-group women (5.1%), OR 7.0 versus placebo, 95% CI 2.4-20.3, P=.0002.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "These are not clinical liver-failure/death ORs or event counts. Direct clinical-event denominators/effects remain separately unverified.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate original liver-function abnormality and clinical-event tables" }, { "item_id": "N19", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are all ALT events distinguished from person-level liver-function abnormalities?", "needed": "Test events, people, repeated tests, time-specific denominators and original values", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Test events, people, repeated tests, time-specific denominators and original values; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish repeated-test events from person-level and clinical events", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The original research account gives all ALT-elevation events as 53 (6.7%) versus 4 (0.7%), a different count from 26 women with moderate-or-worse abnormalities.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Original numbers are retained; test events are not converted into unique people, liver failure or death. Exact percentage denominators, repeated-event handling and original tables remain unread; values are not recalculated.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "ALT events, people, time-specific counts and original denominator tables" }, { "item_id": "N20", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are mean ALT/AST changes clinical-event effects?", "needed": "Separate enzyme changes, between-group differences/intervals and clinical-event outcomes", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Separate enzyme changes, between-group differences/intervals and clinical-event outcomes; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Separate biochemical changes from clinical harm outcomes", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "ALT +5.4 U/L (95% CI 3.6-7.1) and AST +3.8 U/L (95% CI 2.5-5.1), both P<.001, are retained.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Mean enzyme changes are not used to calculate liver-failure/death risk or events. Confidence intervals of other outcomes are not copied.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original enzyme-change and direct clinical-event results" }, { "item_id": "N21", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are severe enzyme cases direct clinical liver failure or death?", "needed": "Individual test results, clinical course, assessment and severity", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Individual test results, clinical course, assessment and severity; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish enzyme-grade cases from direct clinical outcomes", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The original account reports one grade 4 case with peak ALT 2,055 U/L, six grade 3 cases and seven grade 2 cases, all in the extract group.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "These numbers are not added to create a new severe total or liver-failure/death events. Individual clinical diagnoses, death causes and event outcomes are unverified.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original courses, diagnoses and event assessments for those cases" }, { "item_id": "N22", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "What is the causal scope of withdrawal/rechallenge responses?", "needed": "Test values, exposure/time relationships and direct clinical-event courses", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Test values, exposure/time relationships and direct clinical-event courses; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish re-exposure enzyme responses from direct clinical-event courses", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "Normalization after withdrawal and renewed elevation after rechallenge are preserved summary evidence of enzyme harm.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "This is not extended into clinical liver-failure/death replication or direct causal certification. No withdrawal/rechallenge instructions are created.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original exposure, testing and clinical-course case materials" }, { "item_id": "N23", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Do study safety monitoring and interruption criteria differ from clinical-event observation?", "needed": "Study context of testing schedules, exposure changes, follow-up and event confirmation", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Study context of testing schedules, exposure changes, follow-up and event confirmation; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish the study safety-monitoring context from clinical-event observation scope", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The original study describes monthly tests during the first six months and at months 9/12, with safety-monitoring/interruption rules. This is study context, not treatment guidance.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Effects of monitoring/interruption on direct liver-failure/death follow-up and related analysis details remain unread. They are not converted into efficacy-important differences or general prescribing rules.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study monitoring, exposure changes and post-interruption clinical follow-up" }, { "item_id": "N24", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Can twelve months establish long-term/rare clinical outcomes?", "needed": "Long-term liver-failure/death follow-up, exposure and rare-event denominators", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Long-term liver-failure/death follow-up, exposure and rare-event denominators; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Separate short-term test harms from long-term clinical-event gaps", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The MGTT safety analysis covers 12 months of exposure/observation.", "condition_status": "Unverified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Long-term direct-event follow-up, person-time and rare-event collection are absent from the summary. Twelve-month enzyme findings do not establish long-term events or fill in no events.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term clinical-event/survival follow-up and exposure denominators" }, { "item_id": "N25", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Do other causes, concurrent exposures and withdrawals remain in clinical-event interpretation?", "needed": "Liver-disease causes, other exposures, event timing and interruption/withdrawal data", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Liver-disease causes, other exposures, event timing and interruption/withdrawal data; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Present causal possibilities together with alternative causes and missing-data limits", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The trial involved normal-baseline-enzyme participants; preserved materials include interruption/rechallenge and initial exclusion information.", "condition_status": "Unverified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Without verifying individual alternative causes, follow-up loss and exposure changes, all events are not attributed to extract nor described as unaffected.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinical-event baseline risks, concurrent exposures and original follow-up materials" }, { "item_id": "N26", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are MGTT reports, registration, sibling sheets and EFSA independent trials?", "needed": "Links between papers, registrations, assessments, included trials and populations", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Links between papers, registrations, assessments, included trials and populations; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish reports/assessment documents from actual trials and participant units", "current_reports": [ "R01", "R02" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "Original bibliographies include the MGTT safety paper and EFSA’s 2018 safety opinion. The same parent summary’s enzyme-safety subclaim and selected subclaim share context.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Papers, registration, EFSA, sibling sheets and test times are not added as new independent trials/participants. EFSA inclusion/overlap details remain unread and definitive counts unrecorded.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "MGTT, registration and EFSA included-material relationship tables" }, { "item_id": "N27", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are enzyme signals in other patients same-condition replication?", "needed": "Materials by disease, exposure, duration, comparator and direct endpoint", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Materials by disease, exposure, duration, comparator and direct endpoint; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish unidentified bibliographic context from direct replication of the same question", "current_reports": [ "R01", "R02" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The original counterview mentions similar enzyme directions in at-least-800-mg capsule studies involving HPV lesions, multiple sclerosis, breast cancer and CLL, and some small studies without reported abnormalities.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Missing exact bibliographies, denominators and liver-failure/death outcomes are not filled with new reports. Other disease enzyme signals are not independent replication in normal-enzyme postmenopausal women or repeated clinical-event findings.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual reports, populations and endpoint materials for mentioned diseases" }, { "item_id": "N28", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are selected non-establishment and the parent D verdict distinguished?", "needed": "Original notes/grade reasons and the enzyme-harm/clinical-event boundary", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Original notes/grade reasons and the enzyme-harm/clinical-event boundary; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Display original grades and unverified boundaries for different questions", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The parent counterview says D reflects absent replication rather than weak enzyme harm. The selected ? retains the original verdict that liver failure/death was not established.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Parent D does not erase enzyme harm; selected ? is not safety or no events. No new grade interpretation or reassessment is performed.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Parent verdict rationale and original selected record" }, { "item_id": "N29", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are funding, manufacturing, quality testing and product support distinguished?", "needed": "Funding, manufacturing, quality testing, product/company role disclosures", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Funding, manufacturing, quality testing, product/company role disclosures; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Distinguish public research funding from commercial manufacturing/quality involvement", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The original account reports NIH/NCI federal funding, capsule manufacture by Corban Laboratories and quality-testing involvement by Taiyo International and research institutions.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Manufacturing/quality involvement is not treated as free product support or research funding. Contracts, roles and data control remain externally unread.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding/manufacturing/product/quality disclosures and role specifications" }, { "item_id": "N30", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Do unreported company support and author conflict declarations certify independence?", "needed": "Actual research/analysis/writing/publication funding, author relationships and permissions", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Actual research/analysis/writing/publication funding, author relationships and permissions; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Separate disclosure wording from unverified roles and independence", "current_reports": [ "R01" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The summary says manufacturer research funding, analysis, medical-writing and publication-cost support was not reported, and authors reported no conflicts of interest.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "Non-reporting/declarations do not establish absence of all relationships, employee involvement or data control, or independent liver-failure/death evidence.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Author/support roles, data and publication-permission disclosures" }, { "item_id": "N31", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are summary reading and external abstracts/full text/registration/plans distinguished?", "needed": "Material-specific links, preserved originals and actual reading status", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Material-specific links, preserved originals and actual reading status; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Display summary reading and external non-reading by material type", "current_reports": [ "R01", "R02" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The complete source JSON was read. MGTT PubMed and EFSA URLs follow preserved bibliographies, with external materials marked unread individually.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "External links/clicks, full texts, registrations, protocols and SAP were not accessed. URLs/quotations are not new external reading or completed content review.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original reports, EFSA, registration, protocol and SAP" }, { "item_id": "N32", "question_type": "Harm comparison · Direct clinical-event gaps", "question": "Are Korean/English text, axes, evidence date, corrections, original candidates and preparation events separated?", "needed": "Preserve the full original parent, selected record, metadata and freezing/application", "role": "Required", "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.", "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.", "criterion": "Preserve the full original parent, selected record, metadata and freezing/application; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.", "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification", "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate", "proposed_research": "Record existing verdicts/corrections separately from current preparation/user review", "current_reports": [ "R01", "R02" ], "existence": "Relevant original wording, bibliographies and parent context are in the stored summary; required direct clinical materials remain unverified", "acquired_read": "Summary read; external materials unread", "observation": "The full source retains Korean/English text, axes, 2026-08-26 and empty correction/deliberation records. Original candidate pending/eligibility values are selection history; only the existing subclaim is prepared.", "condition_status": "Partly verified", "status_reason": "The information, scope and direct gaps in the stored summaries read are shown for preparation; this is not review approval or a new clinical harm or safety certification.", "missingness": "The evidence date is not a current review date. Model/content/boundary waits are not activated; existing user-review pending status, false completion, zero new units and unrecorded definite independent counts are retained.", "uncertainty": "External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original source/selected record and freezing/application preparation events" } ], "reports": [ { "report_id": "R01", "title": "Yu Z, et al. Effect of Green Tea Supplements on Liver Enzyme Elevation: Results from a Randomized Intervention Study in the United States. Cancer Prev Res. 2017;10:571-579. PMID: 28765194.", "url": "https://pubmed.ncbi.nlm.nih.gov/28765194/", "report_type": "Stored bibliographic summary of the original trial safety-analysis paper", "existence": "Present in the stored summary’s actual bibliography and related original descriptions", "acquired_read": "Stored summary read; external abstracts, full texts, registrations and plans unread", "independent_replication": "Same report/registration relationship; independent replication not certified", "observed_result": "26 women (5.1%), OR 7.0 (95% CI 2.4-20.3), P=.0002; ALT +5.4 U/L, AST +3.8 U/L", "result_level": "CTCAE liver-function abnormalities and ALT/AST; not liver-failure/death effects", "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, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only" }, { "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, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only" }, { "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, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only" }, { "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, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only" }, { "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, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/28765194/" } ] }, { "report_id": "R02", "title": "EFSA ANS Panel. Scientific opinion on the safety of green tea catechins. EFSA Journal. 2018;16:5239.", "url": "https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5239", "report_type": "Stored bibliographic summary of a safety-assessment report", "existence": "Present in the stored summary’s actual bibliography and related original descriptions", "acquired_read": "Stored summary read; external abstracts, full texts, registrations and plans unread", "independent_replication": "Assessment-report/other-population context is not upgraded into independent replication of the selected clinical events", "observed_result": "The preserved EFSA account associates at least 800 mg EGCG daily from extracts for at least four months with ALT/AST elevations in some participants.", "result_level": "ALT/AST assessment context by EGCG exposure; different from direct clinical-event increases", "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, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only" }, { "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, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only" }, { "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, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only" }, { "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, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only" }, { "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, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only" } ], "links": [ { "label": "Official source", "url": "https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5239" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "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": "MGTT original-trial enzyme-safety analysis, NCT registration and parent/sibling subclaims are connected; these are not directly observed clinical events or new replication trials. EFSA is assessment-report context; included-material/MGTT overlap, unique trials/participants and direct clinical-event effects are unverified." }, "history": [ { "date": "2026-10-12", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-12" }