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

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Harm comparison · Direct clinical-event gapsWhat are the original clinical-event question and subclaim verdict?Required	The selected subclaim is increased liver failure or death, originally graded ?, with the note that the trial did not establish these outcomes. R01	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.	Actual text, grade and note of the increased liver failure/death subclaim	Distinguish the original verdict from current preparation and user-review events
2	Partly verified	Full text not readStored summary read	N02 · Harm comparison · Direct clinical-event gapsAre the parent liver-enzyme safety question and selected clinical events distinguished?Required	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. R01	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.	Distinguish parent claim/analysis endpoints from direct liver-failure/death evidence	Display biochemical harm and direct clinical events as separate questions
3	Unverified	Full text not readStored summary read	N03 · Harm comparison · Direct clinical-event gapsAre the clinical liver-failure definition and assessment pathway provided?Required	The original material records that increased clinical liver failure was not established. The evidence endpoint is CTCAE grade 2-or-higher liver-function abnormality. R01	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.	Clinical liver-failure diagnosis, severity, confirmation and prespecified event definition	Present actual clinical liver-failure confirmation criteria and collection pathways
4	Unverified	Full text not readStored summary read	N04 · Harm comparison · Direct clinical-event gapsAre death causes, types and confirmation methods provided?Required	The selected original wording is increased liver failure or death; the parent summary says increased death was not established. R01	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.	All-cause death, liver-related death, cause confirmation and event definitions	Distinguish direct liver-failure, all-cause death and liver-related death materials
5	Unverified	Full text not readStored summary read	N05 · Harm comparison · Direct clinical-event gapsAre actual liver-failure events, group denominators and follow-up available?Required	The summary read only states that increased clinical liver failure was not established. R01	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.	Liver-failure events, confirmation, observation and withdrawal denominators by group	Present direct events together with actual observed denominators
6	Unverified	Full text not readStored summary read	N06 · Harm comparison · Direct clinical-event gapsAre direct death events, denominators, effects and intervals available?Required	The original boundary that increased death was not established is retained. R01	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.	Deaths, person/time denominators, comparative effects and uncertainty	Present original mortality-comparison values and gaps separately
7	Partly verified	Full text not readStored summary read	N07 · Harm comparison · Direct clinical-event gapsIs missing direct-event collection distinguished from a null-effect test?Required	The original subclaim note says the trial did not establish liver failure/death. R01	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.	Actual collection, reporting, analysis scope and original interpretation	Distinguish non-establishment/unverified information from actual null-effect tests
8	Partly verified	Full text not readStored summary read	N08 · Harm comparison · Direct clinical-event gapsWhat were the actual analysis-population eligibility and baseline enzymes?Required	MGTT’s safety analysis followed 1,021 postmenopausal women aged 50-70 with normal baseline enzymes, 513/508, for 12 months. R01	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.	Age, sex, baseline condition, eligibility and exclusion criteria	Distinguish applicability to normal-baseline participants from other clinical populations
9	Partly verified	Full text not readStored summary read	N09 · Harm comparison · Direct clinical-event gapsAre safety-analysis denominators distinguished from original assignment/exclusions?Required	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. R01	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.	Flow from assignment through baseline, initial testing and safety analysis	Present baseline, early withdrawal, observation and analysis denominators separately
10	Partly verified	Full text not readStored summary read	N10 · Harm comparison · Direct clinical-event gapsWhat were the actual research exposure and duration of high-dose capsules?Required	The parent ingredient identifies research with high-dose green tea extract capsules providing about 843 mg EGCG daily for 12 months. R01	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.	Original EGCG, capsules, actual research exposure, interruption and duration specifications	Distinguish research identity from actual exposure and clinical-event follow-up
11	Unverified	Full text not readStored summary read	N11 · Harm comparison · Direct clinical-event gapsAre placebo/product composition and concurrent exposures verified?Required	The stored evidence is a prespecified safety analysis of a double-blind placebo-controlled randomized trial. R01	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.	Active/placebo composition, matching, caffeine, concurrent exposure and baseline differences	Distinguish selected exposure from other possible causes and comparison conditions
12	Partly verified	Full text not readStored summary read	N12 · Harm comparison · Direct clinical-event gapsDo at least 800 mg/four months and lower-dose contexts answer the same direct question?Required	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. R01 R02	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.	Original other-dose/duration/population materials and direct clinical events	Distinguish dose/duration/population enzyme signals from gaps in direct clinical events
13	Partly verified	Full text not readStored summary read	N13 · Harm comparison · Direct clinical-event gapsAre traditional brewed green tea and concentrated capsules distinguished?Required	The original account explicitly distinguishes traditional brewed green tea from concentrated capsule exposures. R01 R02	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.	Direct evidence by exposure form, composition and duration	Record formulation-specific applicability separately
14	Partly verified	Full text not readStored summary read	N14 · Harm comparison · Direct clinical-event gapsWhat is the current evidence scope for randomization and masking?Required	The original account describes IDS-pharmacy computer-generated block randomization and double masking of staff, participants, laboratory personnel and endpoint assessors. R01	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.	Randomization, concealment, role-specific masking and actual outcomes measured	Distinguish enzyme-analysis methods from direct clinical-event assessment
15	Partly verified	Full text not readStored summary read	N15 · Harm comparison · Direct clinical-event gapsAre the original efficacy primary endpoint and prespecified safety analysis distinguished?Required	The original MGTT efficacy primary endpoint was breast density; the parent verdict concerns a prespecified CTCAE grade 2-or-higher liver-function safety analysis. R01	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.	Planned hierarchy of breast density, safety, liver failure and death	Distinguish planned efficacy, enzyme harm and clinical-event hierarchies
16	Partly verified	Full text not readStored summary read	N16 · Harm comparison · Direct clinical-event gapsAre registration identifiers distinguished from actually read plans?Required	The stored summary describes NCT00917735 and correspondence with the prespecified safety analysis. R01	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.	NCT00917735, registration history, protocol, SAP and event plans	Distinguish preserved identifiers from external reading and direct-event plans
17	Partly verified	Full text not readStored summary read	N17 · Harm comparison · Direct clinical-event gapsDo CTCAE grades differ from clinical liver-failure diagnoses?Required	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. R01	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.	Definitions of biochemical liver-function grades and clinical disease	Separate test-abnormality severity from clinical-event diagnosis
18	Partly verified	Full text not readStored summary read	N18 · Harm comparison · Direct clinical-event gapsWas the parent moderate-or-worse liver-function effect reused?Required	The parent reports 26 extract-group women (5.1%), OR 7.0 versus placebo, 95% CI 2.4-20.3, P=.0002. R01	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.	Distinguish original enzyme-harm events/denominators/effects from direct endpoints	Present parent harm effects and selected clinical-event effects separately
19	Partly verified	Full text not readStored summary read	N19 · Harm comparison · Direct clinical-event gapsAre all ALT events distinguished from person-level liver-function abnormalities?Required	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. R01	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.	Test events, people, repeated tests, time-specific denominators and original values	Distinguish repeated-test events from person-level and clinical events
20	Partly verified	Full text not readStored summary read	N20 · Harm comparison · Direct clinical-event gapsAre mean ALT/AST changes clinical-event effects?Required	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. R01	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.	Separate enzyme changes, between-group differences/intervals and clinical-event outcomes	Separate biochemical changes from clinical harm outcomes
21	Partly verified	Full text not readStored summary read	N21 · Harm comparison · Direct clinical-event gapsAre severe enzyme cases direct clinical liver failure or death?Required	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. R01	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.	Individual test results, clinical course, assessment and severity	Distinguish enzyme-grade cases from direct clinical outcomes
22	Partly verified	Full text not readStored summary read	N22 · Harm comparison · Direct clinical-event gapsWhat is the causal scope of withdrawal/rechallenge responses?Required	Normalization after withdrawal and renewed elevation after rechallenge are preserved summary evidence of enzyme harm. R01	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.	Test values, exposure/time relationships and direct clinical-event courses	Distinguish re-exposure enzyme responses from direct clinical-event courses
23	Partly verified	Full text not readStored summary read	N23 · Harm comparison · Direct clinical-event gapsDo study safety monitoring and interruption criteria differ from clinical-event observation?Required	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. R01	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.	Study context of testing schedules, exposure changes, follow-up and event confirmation	Distinguish the study safety-monitoring context from clinical-event observation scope
24	Unverified	Full text not readStored summary read	N24 · Harm comparison · Direct clinical-event gapsCan twelve months establish long-term/rare clinical outcomes?Required	The MGTT safety analysis covers 12 months of exposure/observation. R01	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.	Long-term liver-failure/death follow-up, exposure and rare-event denominators	Separate short-term test harms from long-term clinical-event gaps
25	Unverified	Full text not readStored summary read	N25 · Harm comparison · Direct clinical-event gapsDo other causes, concurrent exposures and withdrawals remain in clinical-event interpretation?Required	The trial involved normal-baseline-enzyme participants; preserved materials include interruption/rechallenge and initial exclusion information. R01	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.	Liver-disease causes, other exposures, event timing and interruption/withdrawal data	Present causal possibilities together with alternative causes and missing-data limits
26	Partly verified	Full text not readStored summary read	N26 · Harm comparison · Direct clinical-event gapsAre MGTT reports, registration, sibling sheets and EFSA independent trials?Required	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. R01 R02	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.	Links between papers, registrations, assessments, included trials and populations	Distinguish reports/assessment documents from actual trials and participant units
27	Partly verified	Full text not readStored summary read	N27 · Harm comparison · Direct clinical-event gapsAre enzyme signals in other patients same-condition replication?Required	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. R01 R02	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.	Materials by disease, exposure, duration, comparator and direct endpoint	Distinguish unidentified bibliographic context from direct replication of the same question
28	Partly verified	Full text not readStored summary read	N28 · Harm comparison · Direct clinical-event gapsAre selected non-establishment and the parent D verdict distinguished?Required	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. R01	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.	Original notes/grade reasons and the enzyme-harm/clinical-event boundary	Display original grades and unverified boundaries for different questions
29	Partly verified	Full text not readStored summary read	N29 · Harm comparison · Direct clinical-event gapsAre funding, manufacturing, quality testing and product support distinguished?Required	The original account reports NIH/NCI federal funding, capsule manufacture by Corban Laboratories and quality-testing involvement by Taiyo International and research institutions. R01	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.	Funding, manufacturing, quality testing, product/company role disclosures	Distinguish public research funding from commercial manufacturing/quality involvement
30	Partly verified	Full text not readStored summary read	N30 · Harm comparison · Direct clinical-event gapsDo unreported company support and author conflict declarations certify independence?Required	The summary says manufacturer research funding, analysis, medical-writing and publication-cost support was not reported, and authors reported no conflicts of interest. R01	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.	Actual research/analysis/writing/publication funding, author relationships and permissions	Separate disclosure wording from unverified roles and independence
31	Partly verified	Full text not readStored summary read	N31 · Harm comparison · Direct clinical-event gapsAre summary reading and external abstracts/full text/registration/plans distinguished?Required	The complete source JSON was read. MGTT PubMed and EFSA URLs follow preserved bibliographies, with external materials marked unread individually. R01 R02	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.	Material-specific links, preserved originals and actual reading status	Display summary reading and external non-reading by material type
32	Partly verified	Full text not readStored summary read	N32 · Harm comparison · Direct clinical-event gapsAre Korean/English text, axes, evidence date, corrections, original candidates and preparation events separated?Required	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. R01 R02	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.	Preserve the full original parent, selected record, metadata and freezing/application	Record existing verdicts/corrections separately from current preparation/user review

No items match your search or filter.

32 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: 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

Evidence and sources

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

R01 · 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

Material type: Stored bibliographic summary of the original trial safety-analysis paper
Materials actually read: Stored summary read; external abstracts, full texts, registrations and plans unread
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Stored bibliographic summary of a safety-assessment report
Materials actually read: Stored summary read; external abstracts, full texts, registrations and plans unread
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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

Report counts versus independent study counts

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.

Review criteria

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

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

Required materials and conditions: Actual text, grade and note of the increased liver failure/death subclaim
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Distinguish parent claim/analysis endpoints from direct liver-failure/death evidence
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Clinical liver-failure diagnosis, severity, confirmation and prespecified event definition
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: All-cause death, liver-related death, cause confirmation and event definitions
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Liver-failure events, confirmation, observation and withdrawal denominators by group
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Deaths, person/time denominators, comparative effects and uncertainty
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Actual collection, reporting, analysis scope and original interpretation
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Age, sex, baseline condition, eligibility and exclusion criteria
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Flow from assignment through baseline, initial testing and safety analysis
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Original EGCG, capsules, actual research exposure, interruption and duration specifications
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Active/placebo composition, matching, caffeine, concurrent exposure and baseline differences
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Original other-dose/duration/population materials and 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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Direct evidence by exposure form, composition and duration
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Randomization, concealment, role-specific masking and actual outcomes measured
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Planned hierarchy of breast density, safety, liver failure and death
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

N16 · Are registration identifiers distinguished from actually read plans?

Required materials and conditions: NCT00917735, registration history, protocol, SAP and 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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Definitions of biochemical liver-function grades and clinical disease
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Distinguish original enzyme-harm events/denominators/effects from direct endpoints
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Test events, people, repeated tests, time-specific denominators and original values
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Separate enzyme changes, between-group differences/intervals and clinical-event 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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Individual test results, clinical course, assessment and severity
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Test values, exposure/time relationships and 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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Study context of testing schedules, exposure changes, follow-up and event confirmation
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Long-term liver-failure/death follow-up, exposure and rare-event denominators
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Liver-disease causes, other exposures, event timing and interruption/withdrawal data
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Links between papers, registrations, assessments, included trials and populations
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Materials by disease, exposure, duration, comparator and direct endpoint
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Original notes/grade reasons and the enzyme-harm/clinical-event boundary
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Funding, manufacturing, quality testing, product/company role disclosures
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Actual research/analysis/writing/publication funding, author relationships and permissions
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Material-specific links, preserved originals and actual reading status
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

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

Required materials and conditions: Preserve the full original parent, selected record, metadata and freezing/application
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.
Requirement and applicability: Required
Application exceptions: Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.
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.
Referenced methods: Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification

Referenced methods and the sections actually reviewed

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

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

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: 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

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

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: 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

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

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: 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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: 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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: 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/material version 1.0

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

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

Researcher downloads

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

View all item details

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

Current findings: The selected subclaim is increased liver failure or death, originally graded ?, with the note that the trial did not establish these outcomes.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero 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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The selected original wording is increased liver failure or death; the parent summary says increased death was not established.
Verification status: Unverified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The summary read only states that increased clinical liver failure was not established.
Verification status: Unverified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The original boundary that increased death was not established is retained.
Verification status: Unverified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The original subclaim note says the trial did not establish liver failure/death.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: MGTT’s safety analysis followed 1,021 postmenopausal women aged 50-70 with normal baseline enzymes, 513/508, for 12 months.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The parent ingredient identifies research with high-dose green tea extract capsules providing about 843 mg EGCG daily for 12 months.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The stored evidence is a prespecified safety analysis of a double-blind placebo-controlled randomized trial.
Verification status: Unverified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero 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.
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?

Current findings: The original account explicitly distinguishes traditional brewed green tea from concentrated capsule exposures.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The original account describes IDS-pharmacy computer-generated block randomization and double masking of staff, participants, laboratory personnel and endpoint assessors.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The stored summary describes NCT00917735 and correspondence with the prespecified safety analysis.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The parent reports 26 extract-group women (5.1%), OR 7.0 versus placebo, 95% CI 2.4-20.3, P=.0002.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero 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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: Normalization after withdrawal and renewed elevation after rechallenge are preserved summary evidence of enzyme harm.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The MGTT safety analysis covers 12 months of exposure/observation.
Verification status: Unverified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The trial involved normal-baseline-enzyme participants; preserved materials include interruption/rechallenge and initial exclusion information.
Verification status: Unverified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

Current findings: The complete source JSON was read. MGTT PubMed and EFSA URLs follow preserved bibliographies, with external materials marked unread individually.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread
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
Remaining uncertainty: External abstracts, full texts, registrations, protocols and SAPs are unread; failure to establish direct clinical events is not changed into zero events.
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.
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