# High-dose green tea extract · Evidence Check for increased liver failure or death

Verdict 2962 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-12

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: MGTT safety analysis: 1,021 postmenopausal women aged 50-70 with normal baseline enzymes (513/508); direct clinical liver-failure/death event denominators unverified
- Ingredient, formulation and route: 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
- Measured outcome: 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
- Questions outside this scope: No new clinical evidence, effects, confidence intervals, grades, independence certification, event sums or product-intake/monitoring/interruption/rechallenge/treatment instructions

## Checklist items

### N01 · What are the original clinical-event question and subclaim verdict?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: The selected subclaim is increased liver failure or death, originally graded ?, with the note that the trial did not establish these outcomes.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Actual text, grade and note of the increased liver failure/death subclaim
- Materials to obtain first: Original selected subclaim and parent verdict
- Further research: Distinguish the original verdict from current preparation and user-review events
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N02 · Are the parent liver-enzyme safety question and selected clinical events distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Significant enzyme abnormalities are not reused as directly observed effects on clinical liver failure/death.
- Required materials and conditions: Distinguish parent claim/analysis endpoints from direct liver-failure/death evidence
- Materials to obtain first: Original definitions/results for enzyme endpoints and clinical events
- Further research: Display biochemical harm and direct clinical events as separate questions
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N03 · Are the clinical liver-failure definition and assessment pathway provided?

Verification status: Unverified  
Reading scope: Summary read; external materials unread

- Current findings: The original material records that increased clinical liver failure was not established. The evidence endpoint is CTCAE grade 2-or-higher liver-function abnormality.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Clinical liver-failure diagnosis, severity, confirmation and prespecified event definition
- Materials to obtain first: Liver-failure event definitions, assessment materials and plans
- Further research: Present actual clinical liver-failure confirmation criteria and collection pathways
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N04 · Are death causes, types and confirmation methods provided?

Verification status: Unverified  
Reading scope: Summary read; external materials unread

- Current findings: The selected original wording is increased liver failure or death; the parent summary says increased death was not established.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: All-cause death, liver-related death, cause confirmation and event definitions
- Materials to obtain first: Death definitions, cause assessments and follow-up materials
- Further research: Distinguish direct liver-failure, all-cause death and liver-related death materials
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N05 · Are actual liver-failure events, group denominators and follow-up available?

Verification status: Unverified  
Reading scope: Summary read; external materials unread

- Current findings: The summary read only states that increased clinical liver failure was not established.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Liver-failure events, confirmation, observation and withdrawal denominators by group
- Materials to obtain first: Original liver-failure events, group analyses and follow-up tables
- Further research: Present direct events together with actual observed denominators
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N06 · Are direct death events, denominators, effects and intervals available?

Verification status: Unverified  
Reading scope: Summary read; external materials unread

- Current findings: The original boundary that increased death was not established is retained.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Deaths, person/time denominators, comparative effects and uncertainty
- Materials to obtain first: Original group death events, denominators and direct effects
- Further research: Present original mortality-comparison values and gaps separately
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N07 · Is missing direct-event collection distinguished from a null-effect test?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: The original subclaim note says the trial did not establish liver failure/death.
- Why unverified: 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.
- Reason for missing information: Absent details of direct-event collection/testing are not turned into a statistically null mortality trial or proof of equivalence.
- Required materials and conditions: Actual collection, reporting, analysis scope and original interpretation
- Materials to obtain first: Clinical-event collection/analysis specifications and original results
- Further research: Distinguish non-establishment/unverified information from actual null-effect tests
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N08 · What were the actual analysis-population eligibility and baseline enzymes?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: MGTT’s safety analysis followed 1,021 postmenopausal women aged 50-70 with normal baseline enzymes, 513/508, for 12 months.
- Why unverified: 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.
- Reason for missing information: This is not generalized as direct risk data for every sex/age, liver disease or abnormal baseline enzymes. Detailed eligibility remains unread.
- Required materials and conditions: Age, sex, baseline condition, eligibility and exclusion criteria
- Materials to obtain first: Original safety-analysis eligibility, baseline characteristics and exclusion tables
- Further research: Distinguish applicability to normal-baseline participants from other clinical populations
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N09 · Are safety-analysis denominators distinguished from original assignment/exclusions?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Flow from assignment through baseline, initial testing and safety analysis
- Materials to obtain first: Original assignment, safety-analysis and clinical-event flow tables
- Further research: Present baseline, early withdrawal, observation and analysis denominators separately
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N10 · What were the actual research exposure and duration of high-dose capsules?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: The parent ingredient identifies research with high-dose green tea extract capsules providing about 843 mg EGCG daily for 12 months.
- Why unverified: 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.
- Reason for missing information: No new intake, product-use or treatment instructions are created. Assigned versus actual exposure, interruption and clinical-event timing details are unverified.
- Required materials and conditions: Original EGCG, capsules, actual research exposure, interruption and duration specifications
- Materials to obtain first: Trial capsule, exposure/adherence/interruption and event-timing materials
- Further research: Distinguish research identity from actual exposure and clinical-event follow-up
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N11 · Are placebo/product composition and concurrent exposures verified?

Verification status: Unverified  
Reading scope: Summary read; external materials unread

- Current findings: The stored evidence is a prespecified safety analysis of a double-blind placebo-controlled randomized trial.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Active/placebo composition, matching, caffeine, concurrent exposure and baseline differences
- Materials to obtain first: Product/placebo specifications, concurrent exposures and baseline tables
- Further research: Distinguish selected exposure from other possible causes and comparison conditions
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N12 · Do at least 800 mg/four months and lower-dose contexts answer the same direct question?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Original other-dose/duration/population materials and direct clinical events
- Materials to obtain first: EFSA materials included by exposure/duration and clinical endpoint
- Further research: Distinguish dose/duration/population enzyme signals from gaps in direct clinical events
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01, R02

### N13 · Are traditional brewed green tea and concentrated capsules distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: The original account explicitly distinguishes traditional brewed green tea from concentrated capsule exposures.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Direct evidence by exposure form, composition and duration
- Materials to obtain first: Original exposure-form and direct clinical-endpoint materials
- Further research: Record formulation-specific applicability separately
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01, R02

### N14 · What is the current evidence scope for randomization and masking?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: The original account describes IDS-pharmacy computer-generated block randomization and double masking of staff, participants, laboratory personnel and endpoint assessors.
- Why unverified: 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.
- Reason for missing information: Preserved quotations and parent B0 are not current completed method verification. Separate liver-failure/death assessment processes remain unread.
- Required materials and conditions: Randomization, concealment, role-specific masking and actual outcomes measured
- Materials to obtain first: Original randomization, masking and clinical-event assessment methods
- Further research: Distinguish enzyme-analysis methods from direct clinical-event assessment
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N15 · Are the original efficacy primary endpoint and prespecified safety analysis distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: The original MGTT efficacy primary endpoint was breast density; the parent verdict concerns a prespecified CTCAE grade 2-or-higher liver-function safety analysis.
- Why unverified: 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.
- Reason for missing information: Prespecified enzyme safety is not converted into a prespecified liver-failure/death primary-endpoint plan.
- Required materials and conditions: Planned hierarchy of breast density, safety, liver failure and death
- Materials to obtain first: Protocol, safety plan and direct clinical-event lists
- Further research: Distinguish planned efficacy, enzyme harm and clinical-event hierarchies
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N16 · Are registration identifiers distinguished from actually read plans?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: The stored summary describes NCT00917735 and correspondence with the prespecified safety analysis.
- Why unverified: 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.
- Reason for missing information: Registration dates/text, changes and liver-failure/death plans remain unread in this run. Identifier existence is not new certification of prespecification.
- Required materials and conditions: NCT00917735, registration history, protocol, SAP and event plans
- Materials to obtain first: Original registration, protocol, SAP and clinical-event plans
- Further research: Distinguish preserved identifiers from external reading and direct-event plans
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N17 · Do CTCAE grades differ from clinical liver-failure diagnoses?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: One CTCAE grade 4 case is not converted into one clinical liver-failure case or one death.
- Required materials and conditions: Definitions of biochemical liver-function grades and clinical disease
- Materials to obtain first: CTCAE classifications, test values and clinical-diagnosis assessments
- Further research: Separate test-abnormality severity from clinical-event diagnosis
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N18 · Was the parent moderate-or-worse liver-function effect reused?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: The parent reports 26 extract-group women (5.1%), OR 7.0 versus placebo, 95% CI 2.4-20.3, P=.0002.
- Why unverified: 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.
- Reason for missing information: These are not clinical liver-failure/death ORs or event counts. Direct clinical-event denominators/effects remain separately unverified.
- Required materials and conditions: Distinguish original enzyme-harm events/denominators/effects from direct endpoints
- Materials to obtain first: Separate original liver-function abnormality and clinical-event tables
- Further research: Present parent harm effects and selected clinical-event effects separately
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N19 · Are all ALT events distinguished from person-level liver-function abnormalities?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Test events, people, repeated tests, time-specific denominators and original values
- Materials to obtain first: ALT events, people, time-specific counts and original denominator tables
- Further research: Distinguish repeated-test events from person-level and clinical events
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N20 · Are mean ALT/AST changes clinical-event effects?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Mean enzyme changes are not used to calculate liver-failure/death risk or events. Confidence intervals of other outcomes are not copied.
- Required materials and conditions: Separate enzyme changes, between-group differences/intervals and clinical-event outcomes
- Materials to obtain first: Original enzyme-change and direct clinical-event results
- Further research: Separate biochemical changes from clinical harm outcomes
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N21 · Are severe enzyme cases direct clinical liver failure or death?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Individual test results, clinical course, assessment and severity
- Materials to obtain first: Original courses, diagnoses and event assessments for those cases
- Further research: Distinguish enzyme-grade cases from direct clinical outcomes
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N22 · What is the causal scope of withdrawal/rechallenge responses?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: Normalization after withdrawal and renewed elevation after rechallenge are preserved summary evidence of enzyme harm.
- Why unverified: 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.
- Reason for missing information: This is not extended into clinical liver-failure/death replication or direct causal certification. No withdrawal/rechallenge instructions are created.
- Required materials and conditions: Test values, exposure/time relationships and direct clinical-event courses
- Materials to obtain first: Original exposure, testing and clinical-course case materials
- Further research: Distinguish re-exposure enzyme responses from direct clinical-event courses
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N23 · Do study safety monitoring and interruption criteria differ from clinical-event observation?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Study context of testing schedules, exposure changes, follow-up and event confirmation
- Materials to obtain first: Study monitoring, exposure changes and post-interruption clinical follow-up
- Further research: Distinguish the study safety-monitoring context from clinical-event observation scope
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N24 · Can twelve months establish long-term/rare clinical outcomes?

Verification status: Unverified  
Reading scope: Summary read; external materials unread

- Current findings: The MGTT safety analysis covers 12 months of exposure/observation.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Long-term liver-failure/death follow-up, exposure and rare-event denominators
- Materials to obtain first: Long-term clinical-event/survival follow-up and exposure denominators
- Further research: Separate short-term test harms from long-term clinical-event gaps
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N25 · Do other causes, concurrent exposures and withdrawals remain in clinical-event interpretation?

Verification status: Unverified  
Reading scope: Summary read; external materials unread

- Current findings: The trial involved normal-baseline-enzyme participants; preserved materials include interruption/rechallenge and initial exclusion information.
- Why unverified: 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.
- Reason for missing information: Without verifying individual alternative causes, follow-up loss and exposure changes, all events are not attributed to extract nor described as unaffected.
- Required materials and conditions: Liver-disease causes, other exposures, event timing and interruption/withdrawal data
- Materials to obtain first: Clinical-event baseline risks, concurrent exposures and original follow-up materials
- Further research: Present causal possibilities together with alternative causes and missing-data limits
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N26 · Are MGTT reports, registration, sibling sheets and EFSA independent trials?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Links between papers, registrations, assessments, included trials and populations
- Materials to obtain first: MGTT, registration and EFSA included-material relationship tables
- Further research: Distinguish reports/assessment documents from actual trials and participant units
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01, R02

### N27 · Are enzyme signals in other patients same-condition replication?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Materials by disease, exposure, duration, comparator and direct endpoint
- Materials to obtain first: Actual reports, populations and endpoint materials for mentioned diseases
- Further research: Distinguish unidentified bibliographic context from direct replication of the same question
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01, R02

### N28 · Are selected non-establishment and the parent D verdict distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Parent D does not erase enzyme harm; selected ? is not safety or no events. No new grade interpretation or reassessment is performed.
- Required materials and conditions: Original notes/grade reasons and the enzyme-harm/clinical-event boundary
- Materials to obtain first: Parent verdict rationale and original selected record
- Further research: Display original grades and unverified boundaries for different questions
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N29 · Are funding, manufacturing, quality testing and product support distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: The original account reports NIH/NCI federal funding, capsule manufacture by Corban Laboratories and quality-testing involvement by Taiyo International and research institutions.
- Why unverified: 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.
- Reason for missing information: Manufacturing/quality involvement is not treated as free product support or research funding. Contracts, roles and data control remain externally unread.
- Required materials and conditions: Funding, manufacturing, quality testing, product/company role disclosures
- Materials to obtain first: Funding/manufacturing/product/quality disclosures and role specifications
- Further research: Distinguish public research funding from commercial manufacturing/quality involvement
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N30 · Do unreported company support and author conflict declarations certify independence?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: The summary says manufacturer research funding, analysis, medical-writing and publication-cost support was not reported, and authors reported no conflicts of interest.
- Why unverified: 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.
- Reason for missing information: Non-reporting/declarations do not establish absence of all relationships, employee involvement or data control, or independent liver-failure/death evidence.
- Required materials and conditions: Actual research/analysis/writing/publication funding, author relationships and permissions
- Materials to obtain first: Author/support roles, data and publication-permission disclosures
- Further research: Separate disclosure wording from unverified roles and independence
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01

### N31 · Are summary reading and external abstracts/full text/registration/plans distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: The complete source JSON was read. MGTT PubMed and EFSA URLs follow preserved bibliographies, with external materials marked unread individually.
- Why unverified: 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.
- Reason for missing information: External links/clicks, full texts, registrations, protocols and SAP were not accessed. URLs/quotations are not new external reading or completed content review.
- Required materials and conditions: Material-specific links, preserved originals and actual reading status
- Materials to obtain first: Original reports, EFSA, registration, protocol and SAP
- Further research: Display summary reading and external non-reading by material type
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01, R02

### N32 · Are Korean/English text, axes, evidence date, corrections, original candidates and preparation events separated?

Verification status: Partly verified  
Reading scope: Summary read; external materials unread

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: 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.
- Required materials and conditions: Preserve the full original parent, selected record, metadata and freezing/application
- Materials to obtain first: Original source/selected record and freezing/application preparation events
- Further research: Record existing verdicts/corrections separately from current preparation/user review
- Conditions for verification: 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.
- Why this condition is needed: Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.
- Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
- Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
- Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification
- Related sources: R01, R02

## Evidence and sources

### R01

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.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/28765194/)

Materials actually read: Stored summary read; external abstracts, full texts, registrations and plans unread  
Findings recorded in the summary: 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  
Record level: CTCAE liver-function abnormalities and ALT/AST; not liver-failure/death effects  
Independent replication: 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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Summary read | Stored summary read | Summary read | A material slot, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only |
| External abstract | Not read | External material unread | Not read | A material slot, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only |
| External full text | Not read | External material unread | Not read | A material slot, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only |
| Original registration | Not read | External material unread | Not read | A material slot, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only |
| Protocol/SAP | Not read | External material unread | Not read | A material slot, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only |

### R02

EFSA ANS Panel. Scientific opinion on the safety of green tea catechins. EFSA Journal. 2018;16:5239.

[Official source](https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2018.5239)

Materials actually read: Stored summary read; external abstracts, full texts, registrations and plans unread  
Findings recorded in the summary: 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.  
Record level: ALT/AST assessment context by EGCG exposure; different from direct clinical-event increases  
Independent replication: 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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Summary read | Stored summary read | Summary read | A material slot, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only |
| External abstract | Not read | External material unread | Not read | A material slot, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only |
| External full text | Not read | External material unread | Not read | A material slot, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only |
| Original registration | Not read | External material unread | Not read | A material slot, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only |
| Protocol/SAP | Not read | External material unread | Not read | A material slot, not certification of full-text acquisition/reading, link verification or independent trial counts; URLs follow preserved bibliographies only |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

## What the statuses mean

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

## Change history

2026-10-12 · Public page/materials 1.0. Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed.