High-ferritin-target intravenous iron × Reduced dialysis, death or cardiovascular events in nondialysis CKD

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 · Evidence conditionWhich existing subclaim and question direction does this sheet preserve?Required	The selected stored summary concerns reduced dialysis, death or cardiovascular events; the selected question and existing verdict record are distinguished. Parent hemoglobin-verdict and other-subclaim context is retained. No new question, split or verdict is created. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Material retaining the selected subclaim-parent relationship, original question and verdict record is needed and remains subject to user review.	Material retaining the selected subclaim-parent relationship, original question and verdict record.	When additional material becomes available, the existing question scope is recorded separately from other questions.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHow are subclaim grade/note and absent score, status and axes distinguished?Required	The selected subclaim grade is ? and its note says the trial was not designed/powered to answer these events. Subclaim score, status and axes are absent from the stored summary, recorded as null and field absence. Parent C, 50 points and axes are not substituted for subclaim values. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Actual selected-subclaim fields and separately retained parent fields is needed and remains subject to user review.	Actual selected-subclaim fields and separately retained parent fields.	If the original subclaim is corrected, the complete pre-change text and change event are preserved.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat historical context do parent C, 50 points, axes, safety and empty values represent?Required	Parent C, 50 points and B/S/R1/I0/E+/B2 are preserved. Precision is unrecorded; coprimary splitting, large hard-endpoint RCT and no-human-study flags are false; grade-override reasons are empty in both languages. Parent safety is caution. These values are not inherited as selected-subclaim scores or newly satisfied conditions. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Complete parent verdict, axes, safety labels and actual change history is needed and remains subject to user review.	Complete parent verdict, axes, safety labels and actual change history.	Even if a new verdict is requested, original grades and production status remain separately preserved.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionHow are original Korean/English, reference dates and correction histories retained?Required	Parent and subclaim explanations in Korean/English are linked as originally written. The original reference date is 2026-08-26; corrections are an empty array and deliberation an empty value. Detailed Korean rates and concise English wording do not overwrite each other. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Complete original text, language-specific explanations, reference dates and additional correction records is needed and remains subject to user review.	Complete original text, language-specific explanations, reference dates and additional correction records.	Added language-specific text or corrections preserve the complete existing version and link as a new event.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhich materials were actually read for this production and which external materials remain unread?Required	The actual production input is the complete stored summary. Abstracts, full texts, registration, protocols, SAPs and original result tables were not accessed. Research-assessment wording in the summary does not mean current external reading. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Acquisition/reading levels and relevant result locations in original source material is needed and remains subject to user review.	Acquisition/reading levels and relevant result locations in original source material.	Separate additional reading must record its scope and time as a new event.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhat are the FIND-CKD report bibliography and registration identity?Required	The stored direct report is Macdougall IC et al., 2014 FIND-CKD, linked to PMID 24891437 and NCT00994318. DOI, PMCID and external registration content are unverified. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Paper bibliography, original full text, registration content and their actual links is needed and remains subject to user review.	Paper bibliography, original full text, registration content and their actual links.	Added report identities must be distinguished as the same trial or separate trials using original material.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionHow do two subclaim sheets share one trial, report and population?Required	The hemoglobin-response and clinical-event sheets share the same FIND-CKD report/population. Hemoglobin, dialysis, death, infection or two sheets are not added as independent trials/participants. One stored bibliographic entry does not certify a unique trial count. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original material distinguishing trial, report, population, group, outcome links and overlap is needed and remains subject to user review.	Original material distinguishing trial, report, population, group, outcome links and overlap.	New follow-up/related reports link to the existing family; independent replication requires separate material.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhich nondialysis chronic kidney disease anemia population was studied?Required	The parent question concerns iron-deficiency anemia in nondialysis chronic kidney disease. Results are not automatically transferred to dialysis patients, other anemia causes or preoperative preparation. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria is needed and remains subject to user review.	Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria.	Population differences require direct comparison material for the relevant populations.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionHow much is verified about baseline risk and representativeness?Supplementary; required for general application	Detailed age, kidney-disease stage, baseline Hb/iron status, comorbidities and group distributions of clinical-event risk are absent from the current summary. A population name does not establish identical responses in all nondialysis patients. R01	Direct details are unverified within the current stored summary and unread external material. Group baseline tables, recruitment pathways, exclusions, severity and comorbidities is needed and remains subject to user review.	Group baseline tables, recruitment pathways, exclusions, severity and comorbidities.	Application to different risk populations must be distinguished using direct studies with follow-up.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat are the research conditions for high-ferritin-target intravenous ferric carboxymaltose?Required	The historical high-group ferritin target is 400~600 µg/L. It is a trial strategy condition, not an achieved value or a recommended target. It is not extended to other iron formulations/targets. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Intervention strategy, product identity, target-adjustment rules and group achieved values is needed and remains subject to user review.	Intervention strategy, product identity, target-adjustment rules and group achieved values.	Differences by formulation or target require direct strategy-comparison material.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat is the original research exposure of the oral ferrous sulfate control?Required	The original oral control provided 100 mg iron as ferrous sulfate twice daily. This compares an active control with the intravenous-iron strategy; no dosing guidance or dose conversion is created. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Oral formulation, research exposure, actual use, discontinuation and adherence material is needed and remains subject to user review.	Oral formulation, research exposure, actual use, discontinuation and adherence material.	Material with different control conditions is linked separately with those differences specified.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionHow are the selected comparison and other-group information separated in the three-arm design?Required	FIND-CKD is a 56-week multicentre randomized open-label three-arm active-control trial. The selected stored comparison is high-ferritin-target intravenous iron versus oral iron; specific targets, group values and exposure of the other intravenous-iron group are absent from the summary. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans is needed and remains subject to user review.	Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans.	Added other-group results retain separate attribution from the current comparison.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionHow much is known about actual intravenous administration, achieved ferritin, adherence and changes?Required	Intravenous formulation and target strategy are described, but actual doses/frequency, group cumulative exposure, achieved ferritin, oral adherence and changes are unverified in the current summary. R01	Direct details are unverified within the current stored summary and unread external material. Actual group administration, achieved values, adherence, changes and discontinuation records is needed and remains subject to user review.	Actual group administration, achieved values, adherence, changes and discontinuation records.	Exposure differences require material linking actual strategy implementation with outcomes.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionAre starting ESA, transfusions or other iron concurrent care or outcome components?Required	Clinician decisions to start ESA, transfusions or other iron entered the primary composite. Actual treatment frequency, criteria and group courses are absent from the summary, requiring concurrent-management and composite-component roles to be distinguished. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Additional-management initiation criteria, group use/timing and outcome-counting rules is needed and remains subject to user review.	Additional-management initiation criteria, group use/timing and outcome-counting rules.	Interpreting additional management requires plans alongside actual courses.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionAre 56-week follow-up and the weeks 8~52 composite window the same period?Required	The overall design is 56 weeks; the primary composite Hb window is weeks 8~52. Overall follow-up and outcome-specific counting windows are not merged. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up is needed and remains subject to user review.	Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up.	Added timepoint-specific material links each outcome to its relevant period separately.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhat are the randomized, ITT and completed denominators?Required	Stored counts of 626 randomized, 613 ITT and 519 completed are distinguished. The stored summary says 519/626 (82.9%) completed and 17.1% did not complete. These denominators are not applied uniformly to all outcomes and exclusions are not newly calculated. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons is needed and remains subject to user review.	Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons.	Added actual analysis inclusion/missingness rules supplement outcome-specific links.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionHow are group-denominator differences for the primary composite, death and infection recorded?Required	Primary-composite denominators are high-target 153 and oral 308; original death/infection denominators are 154 and 312. These differ; exact analysis-population definitions and exclusion reasons remain externally unread. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables is needed and remains subject to user review.	Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables.	Original explanations of outcome-specific denominators link only to the corresponding rows.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhat effects remain uncertain from noncompletion and missingness?Required	The stored assessment retains historical limitations of 17.1% noncompletion and substantial attrition. Group reasons, outcome-specific missingness, imputation and sensitivity analyses cannot be verified from the summary alone. The historical ≥15% category is not run as a new automatic scoring rule. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material is needed and remains subject to user review.	Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material.	Changes under missingness assumptions must be distinguished using original analyses/additional material.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat is the verification scope of central randomization?Required	The stored account says central interactive voice-response randomization was used. Actual sequence generation, concealment, stratification and implementation details remain externally unread. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Detailed allocation methods, protocols and implementation material is needed and remains subject to user review.	Detailed allocation methods, protocols and implementation material.	Added allocation procedures must retain known levels separately from unverified details.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionWhat distinctions does open-label design require for treatment decisions and laboratory measurement?Required	The original limitation of open-label design and clinician additional-treatment decisions in the primary composite is retained. Laboratory measurement, assessor masking and consistent decision criteria are unverified in detail. No new claim that all Hb tests are inherently subjective is made. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations is needed and remains subject to user review.	Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations.	Material separating component measurement from decision procedures is needed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionWas NCT00994318 registration content actually verified?Required	NCT00994318 is retained as the existing registration identifier. Registration was not opened here; initial registration date, prespecified endpoints, amendments, posted results and paper comparisons remain unverified. R01	Direct details are unverified within the current stored summary and unread external material. Original registration text, versions, endpoints, analyses and changes is needed and remains subject to user review.	Original registration text, versions, endpoints, analyses and changes.	Separately acquired registration material must retain its version and relationship to reports.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAt what level are primary/secondary endpoint and analysis hierarchies known?Required	The parent explanation distinguishes the other-anemia-management/consecutive-low-Hb composite as the exact primary endpoint. Prespecified plans, multiplicity and analysis hierarchy for Hb rise and clinical/safety events remain unread in registration, protocols and SAPs. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables is needed and remains subject to user review.	Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables.	Added plans link prespecified and post hoc distinctions to each outcome.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionWhat original information describes Vifor Pharma sponsorship and oral-iron supply?Required	Stored material specifies Vifor Pharma sponsorship and oral-iron supply. Parent manufacturer-single-trial assessment remains historical. Sponsorship alone does not trigger a new verdict invalidating results. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles is needed and remains subject to user review.	Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles.	Added sponsorship, data-access or analysis-involvement information is recorded separately from interpretation limits.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionWhat are the detailed author conflicts, data-access and publication roles?Supplementary; required for independence claims	Beyond summarized sponsorship/product supply, detailed author conflicts, contracts, data-access/analysis independence and publication decisions are unverified. Unverified information is not changed to absence of conflicts. R01	Direct details are unverified within the current stored summary and unread external material. COI, sponsorship contracts, analysis, data-access and publication-role disclosures is needed and remains subject to user review.	COI, sponsorship contracts, analysis, data-access and publication-role disclosures.	Added independent reports first distinguish actual parties, data sharing and analysis relationships.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionWhat safety scope do stored infection observations cover?Required	Infections were high-target 51/154 (33.1%) versus oral 95/312 (30.4%). Historical wording describing similar infection events is retained alongside inadequate safety power. No absence of increased risk is established. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power is needed and remains subject to user review.	Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power.	Clinically important infection harms require appropriate event collection, follow-up and comparisons.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionAre detailed safety collection, sparse events and attrition verified?Required	Some infection, death and dialysis values exist, but detailed collection methods, recurrent-event handling, assessors, period-specific missingness, severity and original safety tables are unverified. No attempted access is not changed to nonreporting or inaccessibility. R01	Direct details are unverified within the current stored summary and unread external material. Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up is needed and remains subject to user review.	Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up.	Safety signals require material with definitions, ascertainment, denominators and follow-up.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionWhat harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors?Supplementary; required for long-term/safety extension	Results in the selected 56-week population are not extended to long-term/rare harms or safety in other kidney-disease states. Detailed links among baseline disease, concurrent care, treatment selection and events are absent, so sole causation or harmlessness cannot be established. R01	Direct details are unverified within the current stored summary and unread external material. Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events is needed and remains subject to user review.	Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events.	Long-term/rare clinical harms need separate material with sufficient follow-up and appropriate comparisons.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionIs preoperative verdict 2560 for the same drug direct evidence here?Supplementary; required for limits of extension to other settings	Existing citation 2560 concerns preoperative intravenous ferric carboxymaltose and transfusion/death in a different setting, linked as historical D, 34 points. It is not added as direct nondialysis chronic-anemia evidence or a new independent trial entry. That page remains unread.	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Direct material and application limits for different use settings, populations, timepoints and clinical outcomes is needed and remains subject to user review.	Direct material and application limits for different use settings, populations, timepoints and clinical outcomes.	Material from other settings is not merged by drug name alone; question/population differences remain recorded.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionWhat separate questions concern reduced dialysis, death and cardiovascular events?Required	The selected question concerns reduced dialysis, death or cardiovascular events. Subclaim ? and its note that the trial was not designed/powered to answer them are retained. These outcomes do not substitute for each other or form a newly created composite. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates is needed and remains subject to user review.	Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates.	The three outcomes need material with individual definitions and adequate power.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionWhat are the original dialysis-initiation events and denominators?Required	Original wording reports 16 people overall (2.6%) starting dialysis over 56 weeks. Group events/denominators and the population used for the overall proportion are unverified. No new calculation selects arbitrarily among 626, 613 or 519. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables is needed and remains subject to user review.	Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables.	Dialysis initiation requires sufficient follow-up and direct between-group comparisons.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionHow does no-group-difference wording differ from dialysis effects and precision?Required	Both Korean and English say no group difference in dialysis initiation. Detailed between-group effects, CIs, P values and power are absent; no equivalence, noninferiority or zero difference is certified. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models is needed and remains subject to user review.	Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models.	Reduced dialysis must be answered directly by clinical comparisons with sufficient precision.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat are the original group mortality events, denominators and proportions?Required	Deaths were high-target 7/154 (4.5%) versus oral 15/312 (4.8%). Only original denominators/proportions are retained; absent differences, RRs, HRs, P values and CIs are not calculated. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original mortality tables, group analysis populations, follow-up, effects and precision is needed and remains subject to user review.	Original mortality tables, group analysis populations, follow-up, effects and precision.	Direct mortality-reduction comparisons need sufficient events and follow-up.
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionWere deaths defined as all-cause or cause-specific mortality?Required	The summary provides death counts, but detailed all-cause/cause-specific definitions, ascertainment, adjudication and cause distributions are unverified. The same numbers are not changed to cardiovascular-death counts. R01	Direct details are unverified within the current stored summary and unread external material. Death counting, cause ascertainment, adjudication, classification and relatedness material is needed and remains subject to user review.	Death counting, cause ascertainment, adjudication, classification and relatedness material.	Cause-specific mortality requires direct definitions and event adjudication.
34	Unverified	Full text not readStored summary read	N34 · Evidence conditionAre cardiovascular-event definitions, components, counts and denominators verified?Required	The original explanation says reduced cardiovascular events cannot be concluded, but detailed definitions/components, group counts/denominators, periods, effects and CIs are absent from the summary. Zero occurrence or complete nonmeasurement is not newly established. R01	Direct details are unverified within the current stored summary and unread external material. Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals is needed and remains subject to user review.	Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals.	Cardiovascular benefits require direct results, power and follow-up material.
35	Unverified	Full text not readStored summary read	N35 · Evidence conditionCan the three clinical events be calculated as one composite?Required	The three events are described clinical-outcome categories; a single planned dialysis/death/cardiovascular composite definition or original composite effect is absent. Outcomes are not newly combined or events/participants independently added. R01	Direct details are unverified within the current stored summary and unread external material. If an actual clinical composite exists, its prespecified definition, overlap, first events and component material is needed and remains subject to user review.	If an actual clinical composite exists, its prespecified definition, overlap, first events and component material.	Original plans/tables must distinguish individual outcomes from composites.
36	Partly verified	Full text not readStored summary read	N36 · Evidence conditionWhat are the prespecified design and power for clinical events?Required	The selected note says the trial was not designed/powered to answer these events. The parent also describes insufficient power for safety events. Specific hypotheses, sample-size calculations, expected events, allowed effects and hierarchy values are unverified. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy is needed and remains subject to user review.	Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy.	Clinical benefits require comparisons designed to answer them directly with sufficient events/follow-up.
37	Unverified	Full text not readStored summary read	N37 · Evidence conditionWhat does absent clinical-event CI/precision information mean?Required	Some dialysis/death observations exist, but CIs, P values and precision for reductions are unverified. Hb-composite or Hb-rise intervals are not transferred to clinical events. R01	Direct details are unverified within the current stored summary and unread external material. Event-specific between-group effects, intervals, time models, missingness and analysis plans is needed and remains subject to user review.	Event-specific between-group effects, intervals, time models, missingness and analysis plans.	Material giving direct event-specific estimates and intervals is needed.
38	Partly verified	Full text not readStored summary read	N38 · Evidence conditionHow are randomized, analysis-population and at-risk denominators distinguished?Required	626 randomized, 613 ITT and 519 completed are distinguished from clinical-event denominators 154/312. The denominator for the overall 16 dialysis starters and event-specific analysis-population details are not arbitrarily selected. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules is needed and remains subject to user review.	Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules.	Overall flows and outcome-specific analysis tables are needed to supplement clinical-event attribution.
39	Unverified	Full text not readStored summary read	N39 · Evidence conditionWhat are actual clinical-event follow-up, censoring and missingness?Required	The 56-week design and original Korean dialysis/death context over 56 weeks are retained. Event origins, at-risk periods, follow-up retrieval, censoring, missingness and post-treatment-change follow-up are unverified in detail. R01	Direct details are unverified within the current stored summary and unread external material. Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules is needed and remains subject to user review.	Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules.	Long-term clinical outcomes need sufficient follow-up and original at-risk populations.
40	Partly verified	Full text not readStored summary read	N40 · Evidence conditionHow do observed clinical events differ from demonstrated reduction effects?Required	Dialysis/death values are not deleted as though none were observed. Some descriptive observations and no-group-difference wording are retained, distinguished from results designed/powered to demonstrate reductions. Cardiovascular details remain unverified. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Observation methods, purpose, analyses, power and between-group clinical outcomes is needed and remains subject to user review.	Observation methods, purpose, analyses, power and between-group clinical outcomes.	Beyond descriptive event reports, direct comparisons answering the reduction claim are needed.
41	Partly verified	Full text not readStored summary read	N41 · Evidence conditionIs primary-composite improvement improved dialysis, mortality or cardiovascular outcomes?Required	The primary composite is other anemia management or consecutive Hb <10 g/dL during weeks 8~52: 36/153 (23.5%) versus 98/308 (31.8%), HR 0.65 (95% CI 0.44~0.95). This laboratory/treatment-decision composite is not transferred to selected clinical-event effects. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships is needed and remains subject to user review.	Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships.	Material directly measuring/testing each clinical outcome is needed.
42	Partly verified	Full text not readStored summary read	N42 · Evidence conditionDoes the Hb ≥1 g/dL response HR answer the selected clinical events?Required	Hb ≥1 g/dL rise HR 2.04 (95% CI 1.52~2.72) is a reported hemoglobin response. It is not changed to dialysis, mortality or cardiovascular HRs, survival time or patient-event response rates. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Separate Hb-response and patient-event outcomes, definitions, periods and denominators is needed and remains subject to user review.	Separate Hb-response and patient-event outcomes, definitions, periods and denominators.	Direct outcome material answering clinical benefit is needed.
43	Partly verified	Full text not readStored summary read	N43 · Evidence conditionHow do unverified efficacy, safety, harmlessness and equivalence differ?Required	The original limitation that clinical-event reductions were not established remains alongside inadequate safety power. Historical similar mortality/infection proportions alone do not establish harmlessness, equivalence or safety noninferiority. R01	Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power is needed and remains subject to user review.	Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power.	Material directly answering each question, including rare/long-term harms, is needed.
44	Unverified	Full text not readStored summary read	N44 · Evidence conditionCan application extend to other populations, dialysis states, eras or management strategies?Supplementary; required for extending applicability	Current evidence compares the original intravenous-iron target strategy with oral iron in nondialysis CKD iron-deficiency anemia. Clinical-event reductions across other dialysis states, formulations, ferritin targets, baseline risks or treatment eras are not automatically established. R01	Direct details are unverified within the current stored summary and unread external material. Direct comparisons showing population, management, exposure and era differences is needed and remains subject to user review.	Direct comparisons showing population, management, exposure and era differences.	Clinical benefits under other conditions require material for the relevant population, strategy and follow-up.
45	Unverified	Full text not readStored summary read	N45 · Evidence conditionWhat limits are retained when new direct material, follow-up reports or corrections are added?Required (update/independence limits)	Current direct-report sharing across two subclaim questions is retained. Follow-up reports of the same trial are not counted as new independent trials; independent clinical-event trials and long-term material are unverified. New material/corrections record the complete pre-change stored summary and separate events. R01	Direct details are unverified within the current stored summary and unread external material. New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons is needed and remains subject to user review.	New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons.	Condition versions and observation-application events remain separate with user-review scope retained.

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45 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: Hemoglobin response in iron-deficiency anemia with nondialysis chronic kidney disease
Ingredient, formulation and route: High-ferritin-target intravenous ferric carboxymaltose
Dose: The ferritin 400~600 µg/L target and oral iron 100 mg twice daily are retained only as historical research conditions. Actual intravenous doses, frequency and achieved values are unverified; no dose conversions or use guidance are created.
Comparator: Oral ferrous sulfate active control. Details of the other group in the three-arm design are unverified in the current summary.
Measured outcome: Direct questions of reduced dialysis, death or cardiovascular events. Some dialysis/death observations are retained; power for clinical benefit and cardiovascular details are unverified.
Duration: 56-week design; the primary composite Hb criterion concerns weeks 8~52. Exact analysis origins, follow-up and censoring for each clinical event are unverified.
Questions outside this scope: Extending surrogate outcomes to dialysis, survival or cardiovascular protection; Generalizing to all iron formulations, ferritin targets, dialysis states or long-term safety; Administration, treatment-target, dialysis or treatment-suitability recommendations; Adding the same report, trial, population, two sheets or events as independent replication

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 · Macdougall IC, Bock AH, Carrera F, et al. FIND-CKD. Nephrol Dial Transplant. 2014;29(11):2075-2084. PMID: 24891437.

PubMed

Material type: 56-week multicentre randomized open-label three-arm active-control trial
Materials actually read: Summary read; external papers and registration unread
Findings recorded in the stored summary: 23.5% versus 31.8%; HR 0.65 (0.44~0.95), absolute difference -8.3%p, NNT 12
Record level: Original research-assessment wording in the stored summary
Study overlap and independent replication: The existing two-sheet structure separates Hb-centred and clinical-event outcomes from the same FIND-CKD PMID 24891437, registration identifier NCT00994318, report and population. It shares 626 randomized, 613 ITT, 519 completed and different outcomes/denominators. Existing citation 2560 concerns the same drug in another preoperative setting and is not added as a new trial/participant total for this direct report.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored summary	Stored summary read for production	Summary read	The complete parent stored summary was read for production; the original paper was not acquired/read.
Paper abstract	External material unread; needed	Access not attempted; not obtained	Not read	Only the stored PMID link is connected. Actual abstract content and original numerical locations were not verified.
Full paper	External material unread; needed	Access not attempted; not obtained	Not read	The URL is a bibliographic link; full-text acquisition/accessibility was not verified.
Clinical trial registration	External material unread; needed	Access not attempted; not obtained	Not read	Only the registration identifier is retained. Registration URL/content, initial/amended versions and prespecified plans are unverified.
Study protocol	External material unread; needed	Access not attempted; not obtained	Not read	Original plans for three-group strategies, clinical hypotheses, components, follow-up and additional-treatment rules have not been acquired.
Statistical analysis plan	External material unread; needed	Access not attempted; not obtained	Not read	Detailed hierarchy, time models, analysis populations, missingness, clinical-event power and multiplicity plans have not been acquired.
Original results and safety tables	External material unread; needed	Access not attempted; not obtained	Not read	Original tables are needed to verify Hb composite/response and dialysis, death, cardiovascular and infection event definitions, denominators, models, follow-up and detailed intervals.
Sponsorship and interest disclosures	External material unread; needed	Access not attempted; not obtained	Not read	Beyond summarized sponsorship/oral-iron supply, original author conflicts, data-access, analysis and publication roles have not been acquired.
Related verdict in a different setting	External material unread; needed	Access not attempted; not obtained	Not read	Historical D, 34-point link for the same drug in another preoperative setting. It is not added as a direct clinical report or independent replication here; the page was not read.

Report counts versus independent study counts

The existing two-sheet structure separates Hb-centred and clinical-event outcomes from the same FIND-CKD PMID 24891437, registration identifier NCT00994318, report and population. It shares 626 randomized, 613 ITT, 519 completed and different outcomes/denominators. Existing citation 2560 concerns the same drug in another preoperative setting and is not added as a new trial/participant total for this direct report.

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 · Which existing subclaim and question direction does this sheet preserve?

Required materials and conditions: Material retaining the selected subclaim-parent relationship, original question and verdict record.
Conditions for verification: Which existing subclaim and question direction does this sheet preserve? Distinguish Material retaining the selected subclaim-parent relationship, original question and verdict record in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: Which existing subclaim and question direction does this sheet preserve? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N02 · How are subclaim grade/note and absent score, status and axes distinguished?

Required materials and conditions: Actual selected-subclaim fields and separately retained parent fields.
Conditions for verification: How are subclaim grade/note and absent score, status and axes distinguished? Distinguish Actual selected-subclaim fields and separately retained parent fields in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: How are subclaim grade/note and absent score, status and axes distinguished? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N03 · What historical context do parent C, 50 points, axes, safety and empty values represent?

Required materials and conditions: Complete parent verdict, axes, safety labels and actual change history.
Conditions for verification: What historical context do parent C, 50 points, axes, safety and empty values represent? Distinguish Complete parent verdict, axes, safety labels and actual change history in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Parent scores/axes are historical context and do not fill absent selected-subclaim values.
Why this condition is needed: What historical context do parent C, 50 points, axes, safety and empty values represent? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N04 · How are original Korean/English, reference dates and correction histories retained?

Required materials and conditions: Complete original text, language-specific explanations, reference dates and additional correction records.
Conditions for verification: How are original Korean/English, reference dates and correction histories retained? Distinguish Complete original text, language-specific explanations, reference dates and additional correction records in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Historical cross-check and research-assessment wording does not mean newly completed review.
Why this condition is needed: How are original Korean/English, reference dates and correction histories retained? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N05 · Which materials were actually read for this production and which external materials remain unread?

Required materials and conditions: Acquisition/reading levels and relevant result locations in original source material.
Conditions for verification: Which materials were actually read for this production and which external materials remain unread? Distinguish Acquisition/reading levels and relevant result locations in original source material in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: URLs link sources without being upgraded to reading, link testing or content verification.
Why this condition is needed: Which materials were actually read for this production and which external materials remain unread? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N06 · What are the FIND-CKD report bibliography and registration identity?

Required materials and conditions: Paper bibliography, original full text, registration content and their actual links.
Conditions for verification: What are the FIND-CKD report bibliography and registration identity? Distinguish Paper bibliography, original full text, registration content and their actual links in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: A registration identifier does not verify registration content or certify a unique trial.
Why this condition is needed: What are the FIND-CKD report bibliography and registration identity? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N07 · How do two subclaim sheets share one trial, report and population?

Required materials and conditions: Original material distinguishing trial, report, population, group, outcome links and overlap.
Conditions for verification: How do two subclaim sheets share one trial, report and population? Distinguish Original material distinguishing trial, report, population, group, outcome links and overlap in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: New-unit increment remains 0 and the final independent count remains null.
Why this condition is needed: How do two subclaim sheets share one trial, report and population? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N08 · Which nondialysis chronic kidney disease anemia population was studied?

Required materials and conditions: Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria.
Conditions for verification: Which nondialysis chronic kidney disease anemia population was studied? Distinguish Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Eligibility thresholds or disease stages absent from the current summary are not invented.
Why this condition is needed: Which nondialysis chronic kidney disease anemia population was studied? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N09 · How much is verified about baseline risk and representativeness?

Required materials and conditions: Group baseline tables, recruitment pathways, exclusions, severity and comorbidities.
Conditions for verification: How much is verified about baseline risk and representativeness? Distinguish Group baseline tables, recruitment pathways, exclusions, severity and comorbidities in original material and retain unverified limits.
Requirement and applicability: Supplementary; required for general application
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: How much is verified about baseline risk and representativeness? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N10 · What are the research conditions for high-ferritin-target intravenous ferric carboxymaltose?

Required materials and conditions: Intervention strategy, product identity, target-adjustment rules and group achieved values.
Conditions for verification: What are the research conditions for high-ferritin-target intravenous ferric carboxymaltose? Distinguish Intervention strategy, product identity, target-adjustment rules and group achieved values in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Historical targets are not written as treatment, dose or suitability guidance.
Why this condition is needed: What are the research conditions for high-ferritin-target intravenous ferric carboxymaltose? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N11 · What is the original research exposure of the oral ferrous sulfate control?

Required materials and conditions: Oral formulation, research exposure, actual use, discontinuation and adherence material.
Conditions for verification: What is the original research exposure of the oral ferrous sulfate control? Distinguish Oral formulation, research exposure, actual use, discontinuation and adherence material in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Only original exposure values are retained; no new totals, conversions or use recommendations are calculated.
Why this condition is needed: What is the original research exposure of the oral ferrous sulfate control? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N12 · How are the selected comparison and other-group information separated in the three-arm design?

Required materials and conditions: Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans.
Conditions for verification: How are the selected comparison and other-group information separated in the three-arm design? Distinguish Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Other-group targets, denominators or effects are not inferred or back-calculated from totals.
Why this condition is needed: How are the selected comparison and other-group information separated in the three-arm design? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N13 · How much is known about actual intravenous administration, achieved ferritin, adherence and changes?

Required materials and conditions: Actual group administration, achieved values, adherence, changes and discontinuation records.
Conditions for verification: How much is known about actual intravenous administration, achieved ferritin, adherence and changes? Distinguish Actual group administration, achieved values, adherence, changes and discontinuation records in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: No new administered doses, schedules or unit conversions are created.
Why this condition is needed: How much is known about actual intravenous administration, achieved ferritin, adherence and changes? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N14 · Are starting ESA, transfusions or other iron concurrent care or outcome components?

Required materials and conditions: Additional-management initiation criteria, group use/timing and outcome-counting rules.
Conditions for verification: Are starting ESA, transfusions or other iron concurrent care or outcome components? Distinguish Additional-management initiation criteria, group use/timing and outcome-counting rules in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Treatment switches are not presented as the same outcome as patient events.
Why this condition is needed: Are starting ESA, transfusions or other iron concurrent care or outcome components? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N15 · Are 56-week follow-up and the weeks 8~52 composite window the same period?

Required materials and conditions: Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up.
Conditions for verification: Are 56-week follow-up and the weeks 8~52 composite window the same period? Distinguish Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: Are 56-week follow-up and the weeks 8~52 composite window the same period? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N16 · What are the randomized, ITT and completed denominators?

Required materials and conditions: Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons.
Conditions for verification: What are the randomized, ITT and completed denominators? Distinguish Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: No new differences, proportions or participant totals are created from current numbers.
Why this condition is needed: What are the randomized, ITT and completed denominators? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N17 · How are group-denominator differences for the primary composite, death and infection recorded?

Required materials and conditions: Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables.
Conditions for verification: How are group-denominator differences for the primary composite, death and infection recorded? Distinguish Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: One denominator is not used to recalculate other outcomes or certify common ITT.
Why this condition is needed: How are group-denominator differences for the primary composite, death and infection recorded? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N18 · What effects remain uncertain from noncompletion and missingness?

Required materials and conditions: Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material.
Conditions for verification: What effects remain uncertain from noncompletion and missingness? Distinguish Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Attrition effects, new bias grades or lost-person counts are not calculated.
Why this condition is needed: What effects remain uncertain from noncompletion and missingness? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N19 · What is the verification scope of central randomization?

Required materials and conditions: Detailed allocation methods, protocols and implementation material.
Conditions for verification: What is the verification scope of central randomization? Distinguish Detailed allocation methods, protocols and implementation material in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Central-allocation wording alone does not certify all randomization procedures as appropriate.
Why this condition is needed: What is the verification scope of central randomization? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N20 · What distinctions does open-label design require for treatment decisions and laboratory measurement?

Required materials and conditions: Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations.
Conditions for verification: What distinctions does open-label design require for treatment decisions and laboratory measurement? Distinguish Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: The original three-defect, avoidability and common bias-category wording remains historical only.
Why this condition is needed: What distinctions does open-label design require for treatment decisions and laboratory measurement? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N21 · Was NCT00994318 registration content actually verified?

Required materials and conditions: Original registration text, versions, endpoints, analyses and changes.
Conditions for verification: Was NCT00994318 registration content actually verified? Distinguish Original registration text, versions, endpoints, analyses and changes in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: A registration number is not displayed as actual reading or trial certification.
Why this condition is needed: Was NCT00994318 registration content actually verified? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N22 · At what level are primary/secondary endpoint and analysis hierarchies known?

Required materials and conditions: Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables.
Conditions for verification: At what level are primary/secondary endpoint and analysis hierarchies known? Distinguish Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Parent primary-endpoint wording is not upgraded to direct external-plan verification.
Why this condition is needed: At what level are primary/secondary endpoint and analysis hierarchies known? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N23 · What original information describes Vifor Pharma sponsorship and oral-iron supply?

Required materials and conditions: Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles.
Conditions for verification: What original information describes Vifor Pharma sponsorship and oral-iron supply? Distinguish Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: What original information describes Vifor Pharma sponsorship and oral-iron supply? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N24 · What are the detailed author conflicts, data-access and publication roles?

Required materials and conditions: COI, sponsorship contracts, analysis, data-access and publication-role disclosures.
Conditions for verification: What are the detailed author conflicts, data-access and publication roles? Distinguish COI, sponsorship contracts, analysis, data-access and publication-role disclosures in original material and retain unverified limits.
Requirement and applicability: Supplementary; required for independence claims
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: What are the detailed author conflicts, data-access and publication roles? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N25 · What safety scope do stored infection observations cover?

Required materials and conditions: Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power.
Conditions for verification: What safety scope do stored infection observations cover? Distinguish Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: No differences, ratios, P values or CIs beyond original values are calculated.
Why this condition is needed: What safety scope do stored infection observations cover? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N26 · Are detailed safety collection, sparse events and attrition verified?

Required materials and conditions: Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up.
Conditions for verification: Are detailed safety collection, sparse events and attrition verified? Distinguish Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: Are detailed safety collection, sparse events and attrition verified? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N27 · What harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors?

Required materials and conditions: Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events.
Conditions for verification: What harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors? Distinguish Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events in original material and retain unverified limits.
Requirement and applicability: Supplementary; required for long-term/safety extension
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: What harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N28 · Is preoperative verdict 2560 for the same drug direct evidence here?

Required materials and conditions: Direct material and application limits for different use settings, populations, timepoints and clinical outcomes.
Conditions for verification: Is preoperative verdict 2560 for the same drug direct evidence here? Distinguish Direct material and application limits for different use settings, populations, timepoints and clinical outcomes in original material and retain unverified limits.
Requirement and applicability: Supplementary; required for limits of extension to other settings
Application exceptions: Another verdict grade is not inherited by this subclaim.
Why this condition is needed: Is preoperative verdict 2560 for the same drug direct evidence here? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N29 · What separate questions concern reduced dialysis, death and cardiovascular events?

Required materials and conditions: Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates.
Conditions for verification: What separate questions concern reduced dialysis, death and cardiovascular events? Distinguish Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Parent C/Hb improvement is not inherited as positive effects or scores for the selected clinical events.
Why this condition is needed: What separate questions concern reduced dialysis, death and cardiovascular events? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N30 · What are the original dialysis-initiation events and denominators?

Required materials and conditions: Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables.
Conditions for verification: What are the original dialysis-initiation events and denominators? Distinguish Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: The overall 16 people are not copied as group-specific values or added as participants.
Why this condition is needed: What are the original dialysis-initiation events and denominators? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N31 · How does no-group-difference wording differ from dialysis effects and precision?

Required materials and conditions: Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models.
Conditions for verification: How does no-group-difference wording differ from dialysis effects and precision? Distinguish Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Historical nonsignificance/no-group-difference wording is not changed to zero effect.
Why this condition is needed: How does no-group-difference wording differ from dialysis effects and precision? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N32 · What are the original group mortality events, denominators and proportions?

Required materials and conditions: Original mortality tables, group analysis populations, follow-up, effects and precision.
Conditions for verification: What are the original group mortality events, denominators and proportions? Distinguish Original mortality tables, group analysis populations, follow-up, effects and precision in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Mortality is not recalculated using primary-composite denominators 153/308.
Why this condition is needed: What are the original group mortality events, denominators and proportions? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N33 · Were deaths defined as all-cause or cause-specific mortality?

Required materials and conditions: Death counting, cause ascertainment, adjudication, classification and relatedness material.
Conditions for verification: Were deaths defined as all-cause or cause-specific mortality? Distinguish Death counting, cause ascertainment, adjudication, classification and relatedness material in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: Were deaths defined as all-cause or cause-specific mortality? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N34 · Are cardiovascular-event definitions, components, counts and denominators verified?

Required materials and conditions: Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals.
Conditions for verification: Are cardiovascular-event definitions, components, counts and denominators verified? Distinguish Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: Are cardiovascular-event definitions, components, counts and denominators verified? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N35 · Can the three clinical events be calculated as one composite?

Required materials and conditions: If an actual clinical composite exists, its prespecified definition, overlap, first events and component material.
Conditions for verification: Can the three clinical events be calculated as one composite? Distinguish If an actual clinical composite exists, its prespecified definition, overlap, first events and component material in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: No new totals of overlapping people/events or composite HRs are created.
Why this condition is needed: Can the three clinical events be calculated as one composite? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N36 · What are the prespecified design and power for clinical events?

Required materials and conditions: Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy.
Conditions for verification: What are the prespecified design and power for clinical events? Distinguish Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Insufficient power is not changed to established absence of clinical effect or a new grade.
Why this condition is needed: What are the prespecified design and power for clinical events? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N37 · What does absent clinical-event CI/precision information mean?

Required materials and conditions: Event-specific between-group effects, intervals, time models, missingness and analysis plans.
Conditions for verification: What does absent clinical-event CI/precision information mean? Distinguish Event-specific between-group effects, intervals, time models, missingness and analysis plans in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Absent CIs, HRs or hypothetical numbers are not invented.
Why this condition is needed: What does absent clinical-event CI/precision information mean? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N38 · How are randomized, analysis-population and at-risk denominators distinguished?

Required materials and conditions: Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules.
Conditions for verification: How are randomized, analysis-population and at-risk denominators distinguished? Distinguish Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Safety, completer and ITT denominators are not certified as identical.
Why this condition is needed: How are randomized, analysis-population and at-risk denominators distinguished? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N39 · What are actual clinical-event follow-up, censoring and missingness?

Required materials and conditions: Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules.
Conditions for verification: What are actual clinical-event follow-up, censoring and missingness? Distinguish Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: What are actual clinical-event follow-up, censoring and missingness? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N40 · How do observed clinical events differ from demonstrated reduction effects?

Required materials and conditions: Observation methods, purpose, analyses, power and between-group clinical outcomes.
Conditions for verification: How do observed clinical events differ from demonstrated reduction effects? Distinguish Observation methods, purpose, analyses, power and between-group clinical outcomes in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: How do observed clinical events differ from demonstrated reduction effects? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N41 · Is primary-composite improvement improved dialysis, mortality or cardiovascular outcomes?

Required materials and conditions: Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships.
Conditions for verification: Is primary-composite improvement improved dialysis, mortality or cardiovascular outcomes? Distinguish Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Original composite HR, absolute difference -8.3%p and NNT 12 are not selected-clinical-event values.
Why this condition is needed: Is primary-composite improvement improved dialysis, mortality or cardiovascular outcomes? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N42 · Does the Hb ≥1 g/dL response HR answer the selected clinical events?

Required materials and conditions: Separate Hb-response and patient-event outcomes, definitions, periods and denominators.
Conditions for verification: Does the Hb ≥1 g/dL response HR answer the selected clinical events? Distinguish Separate Hb-response and patient-event outcomes, definitions, periods and denominators in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Improved surrogates in the hemoglobin-response sheet do not fill the clinical-event question evidence gaps.
Why this condition is needed: Does the Hb ≥1 g/dL response HR answer the selected clinical events? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N43 · How do unverified efficacy, safety, harmlessness and equivalence differ?

Required materials and conditions: Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power.
Conditions for verification: How do unverified efficacy, safety, harmlessness and equivalence differ? Distinguish Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power in original material and retain unverified limits.
Requirement and applicability: Required
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Why this condition is needed: How do unverified efficacy, safety, harmlessness and equivalence differ? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N44 · Can application extend to other populations, dialysis states, eras or management strategies?

Required materials and conditions: Direct comparisons showing population, management, exposure and era differences.
Conditions for verification: Can application extend to other populations, dialysis states, eras or management strategies? Distinguish Direct comparisons showing population, management, exposure and era differences in original material and retain unverified limits.
Requirement and applicability: Supplementary; required for extending applicability
Application exceptions: No product, dose, target, dialysis or treatment-selection recommendations are created.
Why this condition is needed: Can application extend to other populations, dialysis states, eras or management strategies? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

N45 · What limits are retained when new direct material, follow-up reports or corrections are added?

Required materials and conditions: New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons.
Conditions for verification: What limits are retained when new direct material, follow-up reports or corrections are added? Distinguish New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons in original material and retain unverified limits.
Requirement and applicability: Required (update/independence limits)
Application exceptions: No new independent trials, participant aggregation, calculations, reassessment or treatment guidance are run in this production.
Why this condition is needed: What limits are retained when new direct material, follow-up reports or corrections are added? This is needed to distinguish the direct scope of this question from other outcomes.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

What the statuses mean

Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete: Awaiting user review, or actual review remains incomplete.
Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable: Used when the reason it does not apply to the original question is stated.
Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

2026-10-10 · Public page/material version 1.0

Public reader pages and material were prepared from the existing 45 items. No new clinical searches, verification-state changes or scoring were 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 · Which existing subclaim and question direction does this sheet preserve?

Current findings: The selected stored summary concerns reduced dialysis, death or cardiovascular events; the selected question and existing verdict record are distinguished. Parent hemoglobin-verdict and other-subclaim context is retained. No new question, split or verdict is created.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Material retaining the selected subclaim-parent relationship, original question and verdict record is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Material retaining the selected subclaim-parent relationship, original question and verdict record.
Required materials and conditions: Material retaining the selected subclaim-parent relationship, original question and verdict record.
Materials to obtain first: Material retaining the selected subclaim-parent relationship, original question and verdict record.
Further research: When additional material becomes available, the existing question scope is recorded separately from other questions.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Which existing subclaim and question direction does this sheet preserve? Distinguish Material retaining the selected subclaim-parent relationship, original question and verdict record in original material and retain unverified limits.
Why this condition is needed: Which existing subclaim and question direction does this sheet preserve? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N02 · How are subclaim grade/note and absent score, status and axes distinguished?

Current findings: The selected subclaim grade is ? and its note says the trial was not designed/powered to answer these events. Subclaim score, status and axes are absent from the stored summary, recorded as null and field absence. Parent C, 50 points and axes are not substituted for subclaim values.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Actual selected-subclaim fields and separately retained parent fields is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual selected-subclaim fields and separately retained parent fields.
Required materials and conditions: Actual selected-subclaim fields and separately retained parent fields.
Materials to obtain first: Actual selected-subclaim fields and separately retained parent fields.
Further research: If the original subclaim is corrected, the complete pre-change text and change event are preserved.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: How are subclaim grade/note and absent score, status and axes distinguished? Distinguish Actual selected-subclaim fields and separately retained parent fields in original material and retain unverified limits.
Why this condition is needed: How are subclaim grade/note and absent score, status and axes distinguished? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N03 · What historical context do parent C, 50 points, axes, safety and empty values represent?

Current findings: Parent C, 50 points and B/S/R1/I0/E+/B2 are preserved. Precision is unrecorded; coprimary splitting, large hard-endpoint RCT and no-human-study flags are false; grade-override reasons are empty in both languages. Parent safety is caution. These values are not inherited as selected-subclaim scores or newly satisfied conditions.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Complete parent verdict, axes, safety labels and actual change history is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Complete parent verdict, axes, safety labels and actual change history.
Required materials and conditions: Complete parent verdict, axes, safety labels and actual change history.
Materials to obtain first: Complete parent verdict, axes, safety labels and actual change history.
Further research: Even if a new verdict is requested, original grades and production status remain separately preserved.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What historical context do parent C, 50 points, axes, safety and empty values represent? Distinguish Complete parent verdict, axes, safety labels and actual change history in original material and retain unverified limits.
Why this condition is needed: What historical context do parent C, 50 points, axes, safety and empty values represent? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Parent scores/axes are historical context and do not fill absent selected-subclaim values.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N04 · How are original Korean/English, reference dates and correction histories retained?

Current findings: Parent and subclaim explanations in Korean/English are linked as originally written. The original reference date is 2026-08-26; corrections are an empty array and deliberation an empty value. Detailed Korean rates and concise English wording do not overwrite each other.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Complete original text, language-specific explanations, reference dates and additional correction records is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Complete original text, language-specific explanations, reference dates and additional correction records.
Required materials and conditions: Complete original text, language-specific explanations, reference dates and additional correction records.
Materials to obtain first: Complete original text, language-specific explanations, reference dates and additional correction records.
Further research: Added language-specific text or corrections preserve the complete existing version and link as a new event.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: How are original Korean/English, reference dates and correction histories retained? Distinguish Complete original text, language-specific explanations, reference dates and additional correction records in original material and retain unverified limits.
Why this condition is needed: How are original Korean/English, reference dates and correction histories retained? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Historical cross-check and research-assessment wording does not mean newly completed review.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N05 · Which materials were actually read for this production and which external materials remain unread?

Current findings: The actual production input is the complete stored summary. Abstracts, full texts, registration, protocols, SAPs and original result tables were not accessed. Research-assessment wording in the summary does not mean current external reading.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Acquisition/reading levels and relevant result locations in original source material is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Acquisition/reading levels and relevant result locations in original source material.
Required materials and conditions: Acquisition/reading levels and relevant result locations in original source material.
Materials to obtain first: Acquisition/reading levels and relevant result locations in original source material.
Further research: Separate additional reading must record its scope and time as a new event.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Which materials were actually read for this production and which external materials remain unread? Distinguish Acquisition/reading levels and relevant result locations in original source material in original material and retain unverified limits.
Why this condition is needed: Which materials were actually read for this production and which external materials remain unread? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: URLs link sources without being upgraded to reading, link testing or content verification.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N06 · What are the FIND-CKD report bibliography and registration identity?

Current findings: The stored direct report is Macdougall IC et al., 2014 FIND-CKD, linked to PMID 24891437 and NCT00994318. DOI, PMCID and external registration content are unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Paper bibliography, original full text, registration content and their actual links is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Paper bibliography, original full text, registration content and their actual links.
Required materials and conditions: Paper bibliography, original full text, registration content and their actual links.
Materials to obtain first: Paper bibliography, original full text, registration content and their actual links.
Further research: Added report identities must be distinguished as the same trial or separate trials using original material.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What are the FIND-CKD report bibliography and registration identity? Distinguish Paper bibliography, original full text, registration content and their actual links in original material and retain unverified limits.
Why this condition is needed: What are the FIND-CKD report bibliography and registration identity? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: A registration identifier does not verify registration content or certify a unique trial.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N07 · How do two subclaim sheets share one trial, report and population?

Current findings: The hemoglobin-response and clinical-event sheets share the same FIND-CKD report/population. Hemoglobin, dialysis, death, infection or two sheets are not added as independent trials/participants. One stored bibliographic entry does not certify a unique trial count.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original material distinguishing trial, report, population, group, outcome links and overlap is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original material distinguishing trial, report, population, group, outcome links and overlap.
Required materials and conditions: Original material distinguishing trial, report, population, group, outcome links and overlap.
Materials to obtain first: Original material distinguishing trial, report, population, group, outcome links and overlap.
Further research: New follow-up/related reports link to the existing family; independent replication requires separate material.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: How do two subclaim sheets share one trial, report and population? Distinguish Original material distinguishing trial, report, population, group, outcome links and overlap in original material and retain unverified limits.
Why this condition is needed: How do two subclaim sheets share one trial, report and population? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: New-unit increment remains 0 and the final independent count remains null.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N08 · Which nondialysis chronic kidney disease anemia population was studied?

Current findings: The parent question concerns iron-deficiency anemia in nondialysis chronic kidney disease. Results are not automatically transferred to dialysis patients, other anemia causes or preoperative preparation.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria.
Required materials and conditions: Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria.
Materials to obtain first: Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria.
Further research: Population differences require direct comparison material for the relevant populations.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Which nondialysis chronic kidney disease anemia population was studied? Distinguish Nondialysis iron-deficiency anemia eligibility, recruitment and exclusion criteria in original material and retain unverified limits.
Why this condition is needed: Which nondialysis chronic kidney disease anemia population was studied? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Eligibility thresholds or disease stages absent from the current summary are not invented.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N09 · How much is verified about baseline risk and representativeness?

Current findings: Detailed age, kidney-disease stage, baseline Hb/iron status, comorbidities and group distributions of clinical-event risk are absent from the current summary. A population name does not establish identical responses in all nondialysis patients.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. Group baseline tables, recruitment pathways, exclusions, severity and comorbidities is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Group baseline tables, recruitment pathways, exclusions, severity and comorbidities.
Required materials and conditions: Group baseline tables, recruitment pathways, exclusions, severity and comorbidities.
Materials to obtain first: Group baseline tables, recruitment pathways, exclusions, severity and comorbidities.
Further research: Application to different risk populations must be distinguished using direct studies with follow-up.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: How much is verified about baseline risk and representativeness? Distinguish Group baseline tables, recruitment pathways, exclusions, severity and comorbidities in original material and retain unverified limits.
Why this condition is needed: How much is verified about baseline risk and representativeness? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N10 · What are the research conditions for high-ferritin-target intravenous ferric carboxymaltose?

Current findings: The historical high-group ferritin target is 400~600 µg/L. It is a trial strategy condition, not an achieved value or a recommended target. It is not extended to other iron formulations/targets.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Intervention strategy, product identity, target-adjustment rules and group achieved values is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Intervention strategy, product identity, target-adjustment rules and group achieved values.
Required materials and conditions: Intervention strategy, product identity, target-adjustment rules and group achieved values.
Materials to obtain first: Intervention strategy, product identity, target-adjustment rules and group achieved values.
Further research: Differences by formulation or target require direct strategy-comparison material.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What are the research conditions for high-ferritin-target intravenous ferric carboxymaltose? Distinguish Intervention strategy, product identity, target-adjustment rules and group achieved values in original material and retain unverified limits.
Why this condition is needed: What are the research conditions for high-ferritin-target intravenous ferric carboxymaltose? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Historical targets are not written as treatment, dose or suitability guidance.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N11 · What is the original research exposure of the oral ferrous sulfate control?

Current findings: The original oral control provided 100 mg iron as ferrous sulfate twice daily. This compares an active control with the intravenous-iron strategy; no dosing guidance or dose conversion is created.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Oral formulation, research exposure, actual use, discontinuation and adherence material is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Oral formulation, research exposure, actual use, discontinuation and adherence material.
Required materials and conditions: Oral formulation, research exposure, actual use, discontinuation and adherence material.
Materials to obtain first: Oral formulation, research exposure, actual use, discontinuation and adherence material.
Further research: Material with different control conditions is linked separately with those differences specified.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What is the original research exposure of the oral ferrous sulfate control? Distinguish Oral formulation, research exposure, actual use, discontinuation and adherence material in original material and retain unverified limits.
Why this condition is needed: What is the original research exposure of the oral ferrous sulfate control? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Only original exposure values are retained; no new totals, conversions or use recommendations are calculated.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N12 · How are the selected comparison and other-group information separated in the three-arm design?

Current findings: FIND-CKD is a 56-week multicentre randomized open-label three-arm active-control trial. The selected stored comparison is high-ferritin-target intravenous iron versus oral iron; specific targets, group values and exposure of the other intravenous-iron group are absent from the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans.
Required materials and conditions: Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans.
Materials to obtain first: Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans.
Further research: Added other-group results retain separate attribution from the current comparison.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: How are the selected comparison and other-group information separated in the three-arm design? Distinguish Actual three-group allocation, exposure, analysis/control tables and selected-comparison plans in original material and retain unverified limits.
Why this condition is needed: How are the selected comparison and other-group information separated in the three-arm design? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Other-group targets, denominators or effects are not inferred or back-calculated from totals.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N13 · How much is known about actual intravenous administration, achieved ferritin, adherence and changes?

Current findings: Intravenous formulation and target strategy are described, but actual doses/frequency, group cumulative exposure, achieved ferritin, oral adherence and changes are unverified in the current summary.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. Actual group administration, achieved values, adherence, changes and discontinuation records is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Actual group administration, achieved values, adherence, changes and discontinuation records.
Required materials and conditions: Actual group administration, achieved values, adherence, changes and discontinuation records.
Materials to obtain first: Actual group administration, achieved values, adherence, changes and discontinuation records.
Further research: Exposure differences require material linking actual strategy implementation with outcomes.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: How much is known about actual intravenous administration, achieved ferritin, adherence and changes? Distinguish Actual group administration, achieved values, adherence, changes and discontinuation records in original material and retain unverified limits.
Why this condition is needed: How much is known about actual intravenous administration, achieved ferritin, adherence and changes? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: No new administered doses, schedules or unit conversions are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N14 · Are starting ESA, transfusions or other iron concurrent care or outcome components?

Current findings: Clinician decisions to start ESA, transfusions or other iron entered the primary composite. Actual treatment frequency, criteria and group courses are absent from the summary, requiring concurrent-management and composite-component roles to be distinguished.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Additional-management initiation criteria, group use/timing and outcome-counting rules is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Additional-management initiation criteria, group use/timing and outcome-counting rules.
Required materials and conditions: Additional-management initiation criteria, group use/timing and outcome-counting rules.
Materials to obtain first: Additional-management initiation criteria, group use/timing and outcome-counting rules.
Further research: Interpreting additional management requires plans alongside actual courses.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Are starting ESA, transfusions or other iron concurrent care or outcome components? Distinguish Additional-management initiation criteria, group use/timing and outcome-counting rules in original material and retain unverified limits.
Why this condition is needed: Are starting ESA, transfusions or other iron concurrent care or outcome components? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Treatment switches are not presented as the same outcome as patient events.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N15 · Are 56-week follow-up and the weeks 8~52 composite window the same period?

Current findings: The overall design is 56 weeks; the primary composite Hb window is weeks 8~52. Overall follow-up and outcome-specific counting windows are not merged.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up.
Required materials and conditions: Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up.
Materials to obtain first: Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up.
Further research: Added timepoint-specific material links each outcome to its relevant period separately.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Are 56-week follow-up and the weeks 8~52 composite window the same period? Distinguish Original plans/tables for outcome-specific origins, measurement intervals, analysis windows, end and follow-up in original material and retain unverified limits.
Why this condition is needed: Are 56-week follow-up and the weeks 8~52 composite window the same period? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N16 · What are the randomized, ITT and completed denominators?

Current findings: Stored counts of 626 randomized, 613 ITT and 519 completed are distinguished. The stored summary says 519/626 (82.9%) completed and 17.1% did not complete. These denominators are not applied uniformly to all outcomes and exclusions are not newly calculated.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons.
Required materials and conditions: Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons.
Materials to obtain first: Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons.
Further research: Added actual analysis inclusion/missingness rules supplement outcome-specific links.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What are the randomized, ITT and completed denominators? Distinguish Overall/group flowcharts, analysis-population definitions and exclusion/follow-up-discontinuation reasons in original material and retain unverified limits.
Why this condition is needed: What are the randomized, ITT and completed denominators? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: No new differences, proportions or participant totals are created from current numbers.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N17 · How are group-denominator differences for the primary composite, death and infection recorded?

Current findings: Primary-composite denominators are high-target 153 and oral 308; original death/infection denominators are 154 and 312. These differ; exact analysis-population definitions and exclusion reasons remain externally unread.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables.
Required materials and conditions: Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables.
Materials to obtain first: Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables.
Further research: Original explanations of outcome-specific denominators link only to the corresponding rows.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: How are group-denominator differences for the primary composite, death and infection recorded? Distinguish Outcome-specific group, analysis-population, follow-up, missingness and event-counting tables in original material and retain unverified limits.
Why this condition is needed: How are group-denominator differences for the primary composite, death and infection recorded? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: One denominator is not used to recalculate other outcomes or certify common ITT.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N18 · What effects remain uncertain from noncompletion and missingness?

Current findings: The stored assessment retains historical limitations of 17.1% noncompletion and substantial attrition. Group reasons, outcome-specific missingness, imputation and sensitivity analyses cannot be verified from the summary alone. The historical ≥15% category is not run as a new automatic scoring rule.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material.
Required materials and conditions: Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material.
Materials to obtain first: Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material.
Further research: Changes under missingness assumptions must be distinguished using original analyses/additional material.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What effects remain uncertain from noncompletion and missingness? Distinguish Group missingness reasons, follow-up retrieval, analysis handling and sensitivity material in original material and retain unverified limits.
Why this condition is needed: What effects remain uncertain from noncompletion and missingness? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Attrition effects, new bias grades or lost-person counts are not calculated.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N19 · What is the verification scope of central randomization?

Current findings: The stored account says central interactive voice-response randomization was used. Actual sequence generation, concealment, stratification and implementation details remain externally unread.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Detailed allocation methods, protocols and implementation material is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Detailed allocation methods, protocols and implementation material.
Required materials and conditions: Detailed allocation methods, protocols and implementation material.
Materials to obtain first: Detailed allocation methods, protocols and implementation material.
Further research: Added allocation procedures must retain known levels separately from unverified details.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What is the verification scope of central randomization? Distinguish Detailed allocation methods, protocols and implementation material in original material and retain unverified limits.
Why this condition is needed: What is the verification scope of central randomization? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Central-allocation wording alone does not certify all randomization procedures as appropriate.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N20 · What distinctions does open-label design require for treatment decisions and laboratory measurement?

Current findings: The original limitation of open-label design and clinician additional-treatment decisions in the primary composite is retained. Laboratory measurement, assessor masking and consistent decision criteria are unverified in detail. No new claim that all Hb tests are inherently subjective is made.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations.
Required materials and conditions: Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations.
Materials to obtain first: Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations.
Further research: Material separating component measurement from decision procedures is needed.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What distinctions does open-label design require for treatment decisions and laboratory measurement? Distinguish Laboratory/assessor masking, treatment-decision criteria, adjudication and control-group operations in original material and retain unverified limits.
Why this condition is needed: What distinctions does open-label design require for treatment decisions and laboratory measurement? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: The original three-defect, avoidability and common bias-category wording remains historical only.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N21 · Was NCT00994318 registration content actually verified?

Current findings: NCT00994318 is retained as the existing registration identifier. Registration was not opened here; initial registration date, prespecified endpoints, amendments, posted results and paper comparisons remain unverified.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. Original registration text, versions, endpoints, analyses and changes is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original registration text, versions, endpoints, analyses and changes.
Required materials and conditions: Original registration text, versions, endpoints, analyses and changes.
Materials to obtain first: Original registration text, versions, endpoints, analyses and changes.
Further research: Separately acquired registration material must retain its version and relationship to reports.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Was NCT00994318 registration content actually verified? Distinguish Original registration text, versions, endpoints, analyses and changes in original material and retain unverified limits.
Why this condition is needed: Was NCT00994318 registration content actually verified? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: A registration number is not displayed as actual reading or trial certification.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N22 · At what level are primary/secondary endpoint and analysis hierarchies known?

Current findings: The parent explanation distinguishes the other-anemia-management/consecutive-low-Hb composite as the exact primary endpoint. Prespecified plans, multiplicity and analysis hierarchy for Hb rise and clinical/safety events remain unread in registration, protocols and SAPs.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables.
Required materials and conditions: Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables.
Materials to obtain first: Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables.
Further research: Added plans link prespecified and post hoc distinctions to each outcome.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: At what level are primary/secondary endpoint and analysis hierarchies known? Distinguish Prespecified plans, hierarchy, hypotheses, multiple comparisons, analysis versions and original tables in original material and retain unverified limits.
Why this condition is needed: At what level are primary/secondary endpoint and analysis hierarchies known? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Parent primary-endpoint wording is not upgraded to direct external-plan verification.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N23 · What original information describes Vifor Pharma sponsorship and oral-iron supply?

Current findings: Stored material specifies Vifor Pharma sponsorship and oral-iron supply. Parent manufacturer-single-trial assessment remains historical. Sponsorship alone does not trigger a new verdict invalidating results.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles.
Required materials and conditions: Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles.
Materials to obtain first: Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles.
Further research: Added sponsorship, data-access or analysis-involvement information is recorded separately from interpretation limits.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What original information describes Vifor Pharma sponsorship and oral-iron supply? Distinguish Original disclosures of sponsorship, product supply, design, data management, analysis and publication roles in original material and retain unverified limits.
Why this condition is needed: What original information describes Vifor Pharma sponsorship and oral-iron supply? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N24 · What are the detailed author conflicts, data-access and publication roles?

Current findings: Beyond summarized sponsorship/product supply, detailed author conflicts, contracts, data-access/analysis independence and publication decisions are unverified. Unverified information is not changed to absence of conflicts.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. COI, sponsorship contracts, analysis, data-access and publication-role disclosures is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; COI, sponsorship contracts, analysis, data-access and publication-role disclosures.
Required materials and conditions: COI, sponsorship contracts, analysis, data-access and publication-role disclosures.
Materials to obtain first: COI, sponsorship contracts, analysis, data-access and publication-role disclosures.
Further research: Added independent reports first distinguish actual parties, data sharing and analysis relationships.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What are the detailed author conflicts, data-access and publication roles? Distinguish COI, sponsorship contracts, analysis, data-access and publication-role disclosures in original material and retain unverified limits.
Why this condition is needed: What are the detailed author conflicts, data-access and publication roles? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N25 · What safety scope do stored infection observations cover?

Current findings: Infections were high-target 51/154 (33.1%) versus oral 95/312 (30.4%). Historical wording describing similar infection events is retained alongside inadequate safety power. No absence of increased risk is established.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power.
Required materials and conditions: Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power.
Materials to obtain first: Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power.
Further research: Clinically important infection harms require appropriate event collection, follow-up and comparisons.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What safety scope do stored infection observations cover? Distinguish Infection definitions, collection periods, group analysis populations, severity, effects/CIs and planned power in original material and retain unverified limits.
Why this condition is needed: What safety scope do stored infection observations cover? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: No differences, ratios, P values or CIs beyond original values are calculated.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N26 · Are detailed safety collection, sparse events and attrition verified?

Current findings: Some infection, death and dialysis values exist, but detailed collection methods, recurrent-event handling, assessors, period-specific missingness, severity and original safety tables are unverified. No attempted access is not changed to nonreporting or inaccessibility.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up.
Required materials and conditions: Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up.
Materials to obtain first: Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up.
Further research: Safety signals require material with definitions, ascertainment, denominators and follow-up.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Are detailed safety collection, sparse events and attrition verified? Distinguish Original safety tables, collection rules, missingness, discontinuation reasons and event-specific denominators/follow-up in original material and retain unverified limits.
Why this condition is needed: Are detailed safety collection, sparse events and attrition verified? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N27 · What harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors?

Current findings: Results in the selected 56-week population are not extended to long-term/rare harms or safety in other kidney-disease states. Detailed links among baseline disease, concurrent care, treatment selection and events are absent, so sole causation or harmlessness cannot be established.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events.
Required materials and conditions: Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events.
Materials to obtain first: Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events.
Further research: Long-term/rare clinical harms need separate material with sufficient follow-up and appropriate comparisons.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors? Distinguish Material linking long-term follow-up, vulnerable populations, baseline risk, concurrent care, discontinuation and events in original material and retain unverified limits.
Why this condition is needed: What harm-evidence gaps concern long-term outcomes, vulnerable populations and alternative factors? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N28 · Is preoperative verdict 2560 for the same drug direct evidence here?

Current findings: Existing citation 2560 concerns preoperative intravenous ferric carboxymaltose and transfusion/death in a different setting, linked as historical D, 34 points. It is not added as direct nondialysis chronic-anemia evidence or a new independent trial entry. That page remains unread.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Direct material and application limits for different use settings, populations, timepoints and clinical outcomes is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Direct material and application limits for different use settings, populations, timepoints and clinical outcomes.
Required materials and conditions: Direct material and application limits for different use settings, populations, timepoints and clinical outcomes.
Materials to obtain first: Direct material and application limits for different use settings, populations, timepoints and clinical outcomes.
Further research: Material from other settings is not merged by drug name alone; question/population differences remain recorded.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Is preoperative verdict 2560 for the same drug direct evidence here? Distinguish Direct material and application limits for different use settings, populations, timepoints and clinical outcomes in original material and retain unverified limits.
Why this condition is needed: Is preoperative verdict 2560 for the same drug direct evidence here? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Another verdict grade is not inherited by this subclaim.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources

N29 · What separate questions concern reduced dialysis, death and cardiovascular events?

Current findings: The selected question concerns reduced dialysis, death or cardiovascular events. Subclaim ? and its note that the trial was not designed/powered to answer them are retained. These outcomes do not substitute for each other or form a newly created composite.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates.
Required materials and conditions: Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates.
Materials to obtain first: Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates.
Further research: The three outcomes need material with individual definitions and adequate power.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What separate questions concern reduced dialysis, death and cardiovascular events? Distinguish Outcome-specific definitions, plans, populations, denominators, comparisons, periods and direct estimates in original material and retain unverified limits.
Why this condition is needed: What separate questions concern reduced dialysis, death and cardiovascular events? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Parent C/Hb improvement is not inherited as positive effects or scores for the selected clinical events.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N30 · What are the original dialysis-initiation events and denominators?

Current findings: Original wording reports 16 people overall (2.6%) starting dialysis over 56 weeks. Group events/denominators and the population used for the overall proportion are unverified. No new calculation selects arbitrarily among 626, 613 or 519.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables.
Required materials and conditions: Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables.
Materials to obtain first: Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables.
Further research: Dialysis initiation requires sufficient follow-up and direct between-group comparisons.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What are the original dialysis-initiation events and denominators? Distinguish Dialysis definitions, group events, denominators, at-risk populations, timing, follow-up and analysis tables in original material and retain unverified limits.
Why this condition is needed: What are the original dialysis-initiation events and denominators? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: The overall 16 people are not copied as group-specific values or added as participants.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N31 · How does no-group-difference wording differ from dialysis effects and precision?

Current findings: Both Korean and English say no group difference in dialysis initiation. Detailed between-group effects, CIs, P values and power are absent; no equivalence, noninferiority or zero difference is certified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models.
Required materials and conditions: Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models.
Materials to obtain first: Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models.
Further research: Reduced dialysis must be answered directly by clinical comparisons with sufficient precision.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: How does no-group-difference wording differ from dialysis effects and precision? Distinguish Original dialysis between-group analyses, effects, intervals, hypotheses, power and time models in original material and retain unverified limits.
Why this condition is needed: How does no-group-difference wording differ from dialysis effects and precision? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Historical nonsignificance/no-group-difference wording is not changed to zero effect.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N32 · What are the original group mortality events, denominators and proportions?

Current findings: Deaths were high-target 7/154 (4.5%) versus oral 15/312 (4.8%). Only original denominators/proportions are retained; absent differences, RRs, HRs, P values and CIs are not calculated.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original mortality tables, group analysis populations, follow-up, effects and precision is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original mortality tables, group analysis populations, follow-up, effects and precision.
Required materials and conditions: Original mortality tables, group analysis populations, follow-up, effects and precision.
Materials to obtain first: Original mortality tables, group analysis populations, follow-up, effects and precision.
Further research: Direct mortality-reduction comparisons need sufficient events and follow-up.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What are the original group mortality events, denominators and proportions? Distinguish Original mortality tables, group analysis populations, follow-up, effects and precision in original material and retain unverified limits.
Why this condition is needed: What are the original group mortality events, denominators and proportions? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Mortality is not recalculated using primary-composite denominators 153/308.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N33 · Were deaths defined as all-cause or cause-specific mortality?

Current findings: The summary provides death counts, but detailed all-cause/cause-specific definitions, ascertainment, adjudication and cause distributions are unverified. The same numbers are not changed to cardiovascular-death counts.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. Death counting, cause ascertainment, adjudication, classification and relatedness material is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Death counting, cause ascertainment, adjudication, classification and relatedness material.
Required materials and conditions: Death counting, cause ascertainment, adjudication, classification and relatedness material.
Materials to obtain first: Death counting, cause ascertainment, adjudication, classification and relatedness material.
Further research: Cause-specific mortality requires direct definitions and event adjudication.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Were deaths defined as all-cause or cause-specific mortality? Distinguish Death counting, cause ascertainment, adjudication, classification and relatedness material in original material and retain unverified limits.
Why this condition is needed: Were deaths defined as all-cause or cause-specific mortality? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N34 · Are cardiovascular-event definitions, components, counts and denominators verified?

Current findings: The original explanation says reduced cardiovascular events cannot be concluded, but detailed definitions/components, group counts/denominators, periods, effects and CIs are absent from the summary. Zero occurrence or complete nonmeasurement is not newly established.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals.
Required materials and conditions: Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals.
Materials to obtain first: Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals.
Further research: Cardiovascular benefits require direct results, power and follow-up material.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Are cardiovascular-event definitions, components, counts and denominators verified? Distinguish Cardiovascular plans, definitions, ascertainment, group tables, estimates and intervals in original material and retain unverified limits.
Why this condition is needed: Are cardiovascular-event definitions, components, counts and denominators verified? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

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N35 · Can the three clinical events be calculated as one composite?

Current findings: The three events are described clinical-outcome categories; a single planned dialysis/death/cardiovascular composite definition or original composite effect is absent. Outcomes are not newly combined or events/participants independently added.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. If an actual clinical composite exists, its prespecified definition, overlap, first events and component material is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; If an actual clinical composite exists, its prespecified definition, overlap, first events and component material.
Required materials and conditions: If an actual clinical composite exists, its prespecified definition, overlap, first events and component material.
Materials to obtain first: If an actual clinical composite exists, its prespecified definition, overlap, first events and component material.
Further research: Original plans/tables must distinguish individual outcomes from composites.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Can the three clinical events be calculated as one composite? Distinguish If an actual clinical composite exists, its prespecified definition, overlap, first events and component material in original material and retain unverified limits.
Why this condition is needed: Can the three clinical events be calculated as one composite? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: No new totals of overlapping people/events or composite HRs are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

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N36 · What are the prespecified design and power for clinical events?

Current findings: The selected note says the trial was not designed/powered to answer these events. The parent also describes insufficient power for safety events. Specific hypotheses, sample-size calculations, expected events, allowed effects and hierarchy values are unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy.
Required materials and conditions: Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy.
Materials to obtain first: Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy.
Further research: Clinical benefits require comparisons designed to answer them directly with sufficient events/follow-up.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What are the prespecified design and power for clinical events? Distinguish Original outcome-specific hypotheses, power, sample-size/event plans and analysis hierarchy in original material and retain unverified limits.
Why this condition is needed: What are the prespecified design and power for clinical events? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Insufficient power is not changed to established absence of clinical effect or a new grade.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N37 · What does absent clinical-event CI/precision information mean?

Current findings: Some dialysis/death observations exist, but CIs, P values and precision for reductions are unverified. Hb-composite or Hb-rise intervals are not transferred to clinical events.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. Event-specific between-group effects, intervals, time models, missingness and analysis plans is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Event-specific between-group effects, intervals, time models, missingness and analysis plans.
Required materials and conditions: Event-specific between-group effects, intervals, time models, missingness and analysis plans.
Materials to obtain first: Event-specific between-group effects, intervals, time models, missingness and analysis plans.
Further research: Material giving direct event-specific estimates and intervals is needed.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What does absent clinical-event CI/precision information mean? Distinguish Event-specific between-group effects, intervals, time models, missingness and analysis plans in original material and retain unverified limits.
Why this condition is needed: What does absent clinical-event CI/precision information mean? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Absent CIs, HRs or hypothetical numbers are not invented.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N38 · How are randomized, analysis-population and at-risk denominators distinguished?

Current findings: 626 randomized, 613 ITT and 519 completed are distinguished from clinical-event denominators 154/312. The denominator for the overall 16 dialysis starters and event-specific analysis-population details are not arbitrarily selected.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules.
Required materials and conditions: Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules.
Materials to obtain first: Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules.
Further research: Overall flows and outcome-specific analysis tables are needed to supplement clinical-event attribution.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: How are randomized, analysis-population and at-risk denominators distinguished? Distinguish Event-specific inclusion, at-risk populations, follow-up, group denominators and exclusion rules in original material and retain unverified limits.
Why this condition is needed: How are randomized, analysis-population and at-risk denominators distinguished? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Safety, completer and ITT denominators are not certified as identical.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N39 · What are actual clinical-event follow-up, censoring and missingness?

Current findings: The 56-week design and original Korean dialysis/death context over 56 weeks are retained. Event origins, at-risk periods, follow-up retrieval, censoring, missingness and post-treatment-change follow-up are unverified in detail.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules.
Required materials and conditions: Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules.
Materials to obtain first: Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules.
Further research: Long-term clinical outcomes need sufficient follow-up and original at-risk populations.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What are actual clinical-event follow-up, censoring and missingness? Distinguish Original event-specific follow-up, censoring, linkage/ascertainment, missingness and post-change observation rules in original material and retain unverified limits.
Why this condition is needed: What are actual clinical-event follow-up, censoring and missingness? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

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N40 · How do observed clinical events differ from demonstrated reduction effects?

Current findings: Dialysis/death values are not deleted as though none were observed. Some descriptive observations and no-group-difference wording are retained, distinguished from results designed/powered to demonstrate reductions. Cardiovascular details remain unverified.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Observation methods, purpose, analyses, power and between-group clinical outcomes is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Observation methods, purpose, analyses, power and between-group clinical outcomes.
Required materials and conditions: Observation methods, purpose, analyses, power and between-group clinical outcomes.
Materials to obtain first: Observation methods, purpose, analyses, power and between-group clinical outcomes.
Further research: Beyond descriptive event reports, direct comparisons answering the reduction claim are needed.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: How do observed clinical events differ from demonstrated reduction effects? Distinguish Observation methods, purpose, analyses, power and between-group clinical outcomes in original material and retain unverified limits.
Why this condition is needed: How do observed clinical events differ from demonstrated reduction effects? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01

N41 · Is primary-composite improvement improved dialysis, mortality or cardiovascular outcomes?

Current findings: The primary composite is other anemia management or consecutive Hb <10 g/dL during weeks 8~52: 36/153 (23.5%) versus 98/308 (31.8%), HR 0.65 (95% CI 0.44~0.95). This laboratory/treatment-decision composite is not transferred to selected clinical-event effects.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships.
Required materials and conditions: Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships.
Materials to obtain first: Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships.
Further research: Material directly measuring/testing each clinical outcome is needed.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Is primary-composite improvement improved dialysis, mortality or cardiovascular outcomes? Distinguish Separate clinical-event definitions, measurements, between-group outcomes and surrogate relationships in original material and retain unverified limits.
Why this condition is needed: Is primary-composite improvement improved dialysis, mortality or cardiovascular outcomes? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Original composite HR, absolute difference -8.3%p and NNT 12 are not selected-clinical-event values.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

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N42 · Does the Hb ≥1 g/dL response HR answer the selected clinical events?

Current findings: Hb ≥1 g/dL rise HR 2.04 (95% CI 1.52~2.72) is a reported hemoglobin response. It is not changed to dialysis, mortality or cardiovascular HRs, survival time or patient-event response rates.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Separate Hb-response and patient-event outcomes, definitions, periods and denominators is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Separate Hb-response and patient-event outcomes, definitions, periods and denominators.
Required materials and conditions: Separate Hb-response and patient-event outcomes, definitions, periods and denominators.
Materials to obtain first: Separate Hb-response and patient-event outcomes, definitions, periods and denominators.
Further research: Direct outcome material answering clinical benefit is needed.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Does the Hb ≥1 g/dL response HR answer the selected clinical events? Distinguish Separate Hb-response and patient-event outcomes, definitions, periods and denominators in original material and retain unverified limits.
Why this condition is needed: Does the Hb ≥1 g/dL response HR answer the selected clinical events? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Improved surrogates in the hemoglobin-response sheet do not fill the clinical-event question evidence gaps.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

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N43 · How do unverified efficacy, safety, harmlessness and equivalence differ?

Current findings: The original limitation that clinical-event reductions were not established remains alongside inadequate safety power. Historical similar mortality/infection proportions alone do not establish harmlessness, equivalence or safety noninferiority.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
Why unverified: Some stored summary content is linked for presentation; external clinical confirmation/content review is not complete. Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power.
Required materials and conditions: Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power.
Materials to obtain first: Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power.
Further research: Material directly answering each question, including rare/long-term harms, is needed.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: How do unverified efficacy, safety, harmlessness and equivalence differ? Distinguish Separate efficacy/harm hypotheses, event definitions, comparisons, intervals and power in original material and retain unverified limits.
Why this condition is needed: How do unverified efficacy, safety, harmlessness and equivalence differ? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: Stored-summary information is distinguished from unread external material; no numbers, effects or verdicts beyond the original text are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

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N44 · Can application extend to other populations, dialysis states, eras or management strategies?

Current findings: Current evidence compares the original intravenous-iron target strategy with oral iron in nondialysis CKD iron-deficiency anemia. Clinical-event reductions across other dialysis states, formulations, ferritin targets, baseline risks or treatment eras are not automatically established.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. Direct comparisons showing population, management, exposure and era differences is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; Direct comparisons showing population, management, exposure and era differences.
Required materials and conditions: Direct comparisons showing population, management, exposure and era differences.
Materials to obtain first: Direct comparisons showing population, management, exposure and era differences.
Further research: Clinical benefits under other conditions require material for the relevant population, strategy and follow-up.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: Can application extend to other populations, dialysis states, eras or management strategies? Distinguish Direct comparisons showing population, management, exposure and era differences in original material and retain unverified limits.
Why this condition is needed: Can application extend to other populations, dialysis states, eras or management strategies? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: No product, dose, target, dialysis or treatment-selection recommendations are created.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

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N45 · What limits are retained when new direct material, follow-up reports or corrections are added?

Current findings: Current direct-report sharing across two subclaim questions is retained. Follow-up reports of the same trial are not counted as new independent trials; independent clinical-event trials and long-term material are unverified. New material/corrections record the complete pre-change stored summary and separate events.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
Why unverified: Direct details are unverified within the current stored summary and unread external material. New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons is needed and remains subject to user review.
Reason for missing information: External abstracts, full texts, registration, plans and original tables remain unread; New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons.
Required materials and conditions: New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons.
Materials to obtain first: New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons.
Further research: Condition versions and observation-application events remain separate with user-review scope retained.
Remaining uncertainty: Missing information or unread external material does not mean zero effect/events, no paper, access failure or a new grade.
Conditions for verification: What limits are retained when new direct material, follow-up reports or corrections are added? Distinguish New bibliography, registration, population links, direct clinical outcomes, correction versions and reasons in original material and retain unverified limits.
Why this condition is needed: What limits are retained when new direct material, follow-up reports or corrections are added? This is needed to distinguish the direct scope of this question from other outcomes.
Application exceptions: No new independent trials, participant aggregation, calculations, reassessment or treatment guidance are run in this production.
Referenced methods: Family condition definitions linked to the stored summary; no official clinical-method assessment is run.

Related sources R01