Computed from this object's own state — a structural condition is unmet. This is not a fixed disclaimer: the conditions below are each testable, and a build in which they are met renders READY.
In Edoxaban, rivaroxaban and apixaban in venous thromboembolism in patients with cancer, what do the contributing trials show?
In this section: Registration and administrative information (PROSPERO field set) · What this object claims to contain
| Review title | Edoxaban, rivaroxaban and apixaban in venous thromboembolism in patients with cancer |
|---|---|
| Review question (PICO) | In Edoxaban, rivaroxaban and apixaban in venous thromboembolism in patients with cancer, what do the contributing trials show? |
| Population | Adults with active cancer and acute symptomatic VTE |
| Intervention | Direct oral anticoagulant (edoxaban, rivaroxaban, apixaban) |
| Comparator | Low-molecular-weight heparin (dalteparin, enoxaparin) |
| Background / rationale | Not recorded — this object holds no background field, and an introduction generated without one would be argument that no source in this review supports |
| Eligibility criteria | not recorded on the page this object was extracted from |
| Information sources | 0 source layers, listed on the Extraction tab |
| Search strategy | The executed strings, datetimes, filters and hit counts are on the Search tab |
| Study selection process | Not recorded — no screening record was recoverable from the page this object was extracted from, so who screened and how cannot be stated |
| Number of screeners | Not recorded — this object records no screener count |
| Data extraction items | Extracted per trial on this object: registry id; primary publication; arms; per-arm counts and the published effect; the randomised total, separately from the analysed denominator. Fields not listed here were not extracted. |
| Outcomes and prioritisation | Multiple trial-declared outcomes: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 6 Month Bleeding Rate | Recurrent Venous Thromboembolism |
| Risk of bias method | Not recorded — no per-domain RoB-2 assessment exists yet |
| Synthesis methods | Not recorded — no outcome on this object carries a pooled estimate, so no synthesis method was applied |
| Subgroup analyses | Not recorded — this object records no subgroup-analysis field at all, so whether any were prespecified is UNKNOWN -- which is not the same as none having been |
| Meta-bias assessment | Not recorded — no funnel, Egger or Peters value is held on this object, so no meta-bias assessment is claimed |
| Certainty assessment | Not recorded — no GRADE record was recoverable from the page this object was extracted from |
| Funding | Not recorded — no funding statement is recorded for this review |
| Competing interests | Not recorded — no declaration is recorded |
| Built | 2026-08-17T12:06Z |
| Schema | 2-converted-from-extractor |
not recorded on the page this object was extracted from
In this section: Extracted values, and where each came from · References · Included studies · Regulatory documents · Methods and guidance · Sources · Multiple trial-declared outcomes: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 6 Month Bleeding Rate | Recurrent Venous Thromboembolism · Multiple trial-declared outcomes: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 6 Month Bleeding Rate | Recurrent Venous Thromboembolism · What was measured · Pooled result · Contributing trials · Endpoint definitions, read from the registry · Named on this review, contributing nothing to its pool
One row per extracted value. Every row carries the value, the verbatim sentence it was read from, a resolvable link to the source, and whether the number was read or derived. Where any of those is absent the row says so rather than omitting the value.
| Trial / outcome | Value as extracted | Verbatim source sentence | Source links | Read or derived |
|---|---|---|---|---|
| HOKUSAI VTE-Cancer primary | OR 0.94 (95% CI 0.657 to 1.34) | no source sentence recorded — this value cannot be checked against a quoted line here | NCT02073682 | DERIVED by us from extractor recovery from the published page The point estimate and interval shown here are DERIVED, not read: the extractor recovered an estimate and a variance on the analysis scale, and the interval is estimate +/- 1.96*sqrt(variance) back-transformed. No source document was consulted and no source sentence is recorded. |
| SELECT-D primary | OR 0.401 (95% CI 0.166 to 0.971) | no source sentence recorded — this value cannot be checked against a quoted line here | NCT02583191 | DERIVED by us from extractor recovery from the published page The point estimate and interval shown here are DERIVED, not read: the extractor recovered an estimate and a variance on the analysis scale, and the interval is estimate +/- 1.96*sqrt(variance) back-transformed. No source document was consulted and no source sentence is recorded. |
| CARAVAGGIO primary | OR 0.682 (95% CI 0.427 to 1.09) | no source sentence recorded — this value cannot be checked against a quoted line here | NCT03045406 | DERIVED by us from extractor recovery from the published page The point estimate and interval shown here are DERIVED, not read: the extractor recovered an estimate and a variance on the analysis scale, and the interval is estimate +/- 1.96*sqrt(variance) back-transformed. No source document was consulted and no source sentence is recorded. |
| Layer | Source | How it was obtained |
|---|
| Comparator | not recorded on the page this object was extracted from |
|---|---|
| Estimand | not recorded on the page this object was extracted from — random-effects |
| Effect scale | reported on the log scale; nothing is pooled on this outcome |
What is confirmed, stated as prominently as what is wrong. (1) HOKUSAI vte-cancer is extracted correctly in every respect. Its stored counts 67/522 and 71/524 are the registry's own primary-outcome counts exactly, and the page's hazard ratio 0.97 (0.70 to 1.36) is the registry's Cox analysis 0.97 (0.696 to 1.359). (2) CARAVAGGIO is extracted correctly. Its stored counts 32/576 and 46/579 are the registry's own primary-outcome counts exactly. (3) the SELECT-D row's numbers are internally coherent and correct for SELECT-D: 8/101 = 7.9 per cent and 18/102 = 17.6 per cent, matching the percentages in the verbatim sentence quoted beside them. The trial data is right; only the registration key is wrong. (4) arm roles and arm labels are correct on all three trials -- edoxaban against dalteparin, rivaroxaban against low-molecular-weight heparin, apixaban against dalteparin -- and each label matches its registration's own arm titles. No arm is inverted here, which is worth saying because the two topics before this one both had inverted labels. What this withdrawal does not establish: not that direct oral anticoagulants and low-molecular-weight heparin cannot be compared in cancer-associated VTE, and not that these trials cannot be pooled. Three of the four register or report a recurrent-VTE endpoint and those are comparable. What cannot stand is this pool: one endpoint that counts bleeding averaged with two that do not, a misidentified registration, a fourth trial dropped in silence, and a headline reconstructable from nothing. The replacement question is identified and deliberately not taken: pool recurrent VTE only across all four, using Hokusai's recurrent-VTE hazard ratio rather than its composite. It is not taken because computing the ten candidate pools above meant computing that one too, so its answer is already known to whoever would choose the question -- the same rule that parked ABLATION_AF, SGLT2_CKD and DOAC_AF. It also cannot be done honestly until the NCT02583191 identity is resolved, because one of the four trials would be entering it under another trial's registration. Parked.
Multiple trial-declared outcomes: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 6 Month Bleeding Rate | Recurrent Venous Thromboembolism. k = 3.
| Trial | Analysed treatment / control |
OR (95% CI), or events | Source of this cell |
|---|---|---|---|
| HOKUSAI vte-Cancer NCT02073682 | intervention: 522 control: 524 | 0.9395 (0.6566 to 1.344) | : |
| SELECT-D NCT02583191 | intervention: 101 control: 102 | 0.4014 (0.1659 to 0.9712) | : |
| CARAVAGGIO NCT03045406 | intervention: 576 control: 579 | 0.6816 (0.4274 to 1.087) | : |
This outcome's name is a concatenation of the trial-declared outcome titles the converter found, produced automatically -- and reading it left to right is enough to see the problem it was hiding: 'Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event', then a bleeding rate, then recurrent VTE. Three different endpoints, one of them a safety endpoint, presented as one outcome. It is left as it stands rather than tidied, because it is the artefact that shows the mismatch. The definition that matters is recorded per trial from each registration's own record, and is rendered on this page under 'Endpoint definitions, read from the registry'.
What each trial COUNTED, in its own registry record's words, before anything here was pooled. A sentence saying what HAPPENED is not a sentence saying what was COUNTED, and only the second one licenses a pool. Read from the registry on 2026-08-18. Follow the registration link to disagree with any row.
| Trial | Rank in its own trial | Registered outcome measure | Description, verbatim | Analysis set / window |
|---|---|---|---|---|
| HOKUSAI VTE-Cancer NCT02073682 | PRIMARY -- this registration's own primary outcome measure | Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | The registry record carries no description for this outcome. The measure line above is the whole of what is registered. Nothing further was registered -- which is a different fact from nothing further having been read, and the distinction is the reader's to use. | 12 months. The registry record carries NO description for this outcome, only the measure and the time frame. |
| SELECT-D NCT02583191 | PRIMARY -- this registration's own primary outcome measure | Patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with the standard treatment with low molecular weight heparin | The registry record carries no description for this outcome. The measure line above is the whole of what is registered. Nothing further was registered -- which is a different fact from nothing further having been read, and the distinction is the reader's to use. | From randomization to 4 weeks after treatment start -- and the effect stored on this row is a six month recurrent-VTE hazard ratio. |
| Identity conflict on this row. Identity conflict -- the data and the registration belong to different trials, and the registration is the wrong half. NCT02583191 is CONKO-011 / AIO-SUP-0115, sponsored by AIO-Studien-gGmbH in Germany, enrolment 246, whose registered primary outcome is 'Patient-reported treatment satisfaction (convenience) with Rivaroxaban in the treatment of acute VTE in cancer patients in comparison with the standard treatment with low molecular weight heparin', measured from randomization to 4 weeks. It is not SELECT-D. SELECT-D is the UK trial of Young et al., and it is registered as ISRCTN86712308, not on ClinicalTrials.gov. Everything else on this row is SELECT-D and is internally coherent: the page's own record carries pmid 29746227, 'J Clin Oncol 2018; 36(20):2017-2023', and the verbatim sentence 'VTE recurrence at 6 months: 8 (7.9%) rivaroxaban vs 18 (17.6%) dalteparin (HR 0.43; 95% CI, 0.19 to 0.99)' -- and 8/101 = 7.9% and 18/102 = 17.6%, so the counts agree with the percentages they are quoted beside. The trial data is right and the key is wrong. That is the mirror image of the defect this property exists for: PARACHUTE-HF was read as ANSWER-HF because a label was accepted as identity, and the fix was to key on the registration. Here the label is correct and the registration is not -- so keying on the registration, done mechanically, sends a reader to a German satisfaction study and makes every automated read of 'this trial's registered primary endpoint' return the wrong endpoint. Only reading both catches it. Not repaired here. Re-keying to ISRCTN86712308 would put a non-ClinicalTrials.gov registration into an object where every other trial is an NCT, and the registry-read tooling speaks only ClinicalTrials.gov. That is a schema decision. Parked. | ||||
| CARAVAGGIO NCT03045406 | PRIMARY -- this registration's own primary outcome measure | Recurrent Venous Thromboembolism | Primary efficacy outcome: objectively confirmed recurrent VTE occurring during the study period, that means the composite of: · proximal DVT of the lower limbs (symptomatic or unsuspected), DVT of the upper limb (symptomatic), PE (symptomatic or unsuspected) | 6 months. |
Adam VTE (NCT02585713) is counted in the index card's k=4 and contributes nothing to the pool, and nothing on the page says so. Its registered primary outcome is a rate, not a count -- 'The rate (percentage) of patients experiencing major bleeding at 6 months' -- and the registry reports it as 0 per cent of 145 against 2.1 per cent of 142. There are no event counts to have. This review derives every per-trial effect from 2x2 counts, so the trial drops out in silence and k falls from 4 to 3 with no surface saying so. This is the second topic in a row with this exact shape: on DOAC_AF it was rocket af. A count-derived pool silently excludes any trial whose registered primary is a rate, and the published k does not know it. Separately: the page carries publishedHR 0.26 (0.09-0.80) for this trial, which is a RECURRENT-VTE effect. Its registered primary is major bleeding. The number and the endpoint on this row are not the same endpoint.
| Trial | Why it contributes nothing | What the registry holds |
|---|---|---|
| ADAM VTE NCT02585713 | registered primary is a rate, not a count, so no 2x2 table exists for a count-derived pool to use | the registered primary as reported: major bleeding at 6 months, 0 per cent of 145 on apixaban against 2.1 per cent of 142 on dalteparin, as a cumulative incidence treating death without bleeding as a competing risk. |
In this section: Multiple trial-declared outcomes: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 6 Month Bleeding Rate | Recurrent Venous Thromboembolism · Forest plot · Risk of bias · GOSH · Trial-sequential analysis · Meta-regression
Drawn from the same stored estimates the table above lists. Box area is proportional to inverse-variance weight.
x-axis range
⬇ SVG (vector) 2 KB ⬇ PNG 4500x920 120 KB
All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: ba56eac8b92a3f6d), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — forest_fit.eps, 4 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — forest_fit.tiff, 12,129 KB.
Changing the range moves the axis window only. The guides stay labelled with the null and the extremes of the plotted intervals, so no plotted value and no printed number differs between these views — and that is checked at build time, not asserted. Ranges not offered because they would crop the data: 0.5 to 2, 0.25 to 4, 0.7 to 1.3.
⬇ SVG (vector) 1 KB
Only the vector format is offered for this figure, by choice: it is line art — discrete marks, glyphs and labels — which SVG reproduces exactly at any size, so a raster would add weight without adding fidelity. The build was able to rasterise; it was asked not to.
Not drawn, because there is nothing to draw it from.
⬇ SVG (vector) 1 KB ⬇ PNG 3500x540 80 KB
All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: dd33d4f986f7c7c5), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — gosh.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — gosh.tiff, 5,537 KB.
Deliberately not drawn. Every subset meta-analysis of 3 trials is 7 points; a cloud that small cannot show the multimodality GOSH exists to reveal, and a reader would take the picture as evidence of its absence.
⬇ SVG (vector) 1 KB ⬇ PNG 3500x650 87 KB
All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: 25ed9800fdf56614), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — tsa.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — tsa.tiff, 6,665 KB.
TSA boundaries depend entirely on a target information size that must be pre-specified. This review's protocol registers none, so any boundary drawn here would be a parameter chosen after seeing the data -- which is the practice TSA exists to protect against.
⬇ SVG (vector) 1 KB ⬇ PNG 3500x540 87 KB
All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: 2316b730fa24744e), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — bubble.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — bubble.tiff, 5,537 KB.
The protocol pre-specifies no moderator, and at k = 3 a meta-regression would be fitted on 3 points. Not drawn rather than drawn with a caveat: a bubble plot invites reading a slope, and there is no slope here that any reader should read.
In this section: Summary of findings · Reproducibility artifact · Other recorded qualifications
| Outcome | k | Pooled effect | Certainty |
|---|---|---|---|
| Multiple trial-declared outcomes: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 6 Month Bleeding Rate | Recurrent Venous Thromboembolism | 3 | not pooled | See comment12 |
| Canonical object | — |
|---|---|
| Registered at | — — |
| Schema | 2-converted-from-extractor |
| Object last updated | 2026-08-17T12:06Z |
| Source object SHA-256, first 16 hex characters | 38fb7ad074ac8971 |
| Page generated | 2026-08-28 07:27 UTC |
| Generator build | 59b484ca7. The standard this page was built to is NOT ESTABLISHED: this object carries no build_stamp, so the version above is the standard that exists now, not the one this page was built against. |
This page CANNOT be rebuilt from what is recorded here: no canonical object is recorded and no registered commit is recorded. Each figure on the Analysis tab downloads as an SVG carrying exactly the values shown.
Statements this review records about the limits of what it establishes, which are not shown elsewhere on this page. They are reproduced from the object verbatim and are not summarised.
| What the registry holds that the page does not | the registered primary as reported: major bleeding at 6 months, 0 per cent of 145 on apixaban against 2.1 per cent of 142 on dalteparin, as a cumulative incidence treating death without bleeding as a competing risk. |
|---|---|
| Components as the registry states them | recurrent venous thromboembolism; Major bleeding. A composite of an efficacy event and a safety event, counted together as one endpoint. |
| Analysis set as the registry states it | 12 months. The registry record carries NO description for this outcome, only the measure and the time frame. |
| Components as the registry states them | patient-reported treatment satisfaction (convenience). Not a clinical event. See the identity conflict recorded on this trial: the effect stored against this registration is a recurrent-VTE effect that belongs to a different trial. |
| Analysis set as the registry states it | From randomization to 4 weeks after treatment start -- and the effect stored on this row is a six month recurrent-VTE hazard ratio. |
| Components as the registry states them | recurrent venous thromboembolism only, defined by the registry as the composite of proximal DVT of the lower limbs (symptomatic or unsuspected), DVT of the upper limb (symptomatic), and PE (symptomatic or unsuspected). No bleeding component. |
In this section: Paper · Title · Abstract · Introduction · Methods — search · Methods — eligibility criteria · Methods — outcomes sought at every registered rank · Results · Disagreements between sources · Limitations · Reporting guidelines · Note on registration · References · Figure legends · Figures · Trial characteristics · Notes on this record — sections not written, and why · Not reported in this record
Each statement below cites the record it came from; those sources are listed at the end of every section. Where the record holds nothing, the section says so by name rather than being left out, so a procedure that was not carried out can be told from one that simply was never mentioned.
Edoxaban, rivaroxaban and apixaban in venous thromboembolism in patients with cancer1
titleQuestion. In Edoxaban, rivaroxaban and apixaban in venous thromboembolism in patients with cancer, what do the contributing trials show?1
questionBackground. This review asks: In Edoxaban, rivaroxaban and apixaban in venous thromboembolism in patients with cancer, what do the contributing trials show? It examines 3 randomised trials and does not pool them. The outcome sought is Multiple trial-declared outcomes: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 6 Month Bleeding Rate | Recurrent Venous Thromboembolism.1
manuscript.introductionPrimary trials. No bibliographic search for primary trials was run. The 3 included trials were identified by reading named registrations on the dates recorded on each entry. The basis on which this object was verified is not recorded. What this object does not claim is not recorded. The bar this object had to clear is not recorded.1
bookkeeping_2026_08_21.the_search_its_date_and_its_databasesnot recorded on the page this object was extracted from1
screening.eligibilityEvery registered rank -- primary, secondary and other -- was read for 3 of 3 contributing trials before any decision about which outcomes could be combined; each records the time it was read.1
inputs.trials[].all_ranks_read_utcMultiple trial-declared outcomes: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 6 Month Bleeding Rate | Recurrent Venous Thromboembolism. These 3 trials are not pooled, and the reason is stated rather than the outcome being quietly omitted: The three pooled trials do not share one endpoint, and one whole component is present in one and absent from the other two. Hokusai VTE-Cancer's registered primary, verbatim, is 'Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or major bleeding event' at 12 months. Caravaggio's is 'Recurrent Venous Thromboembolism' at 6 months, which its registry description defines as proximal DVT of the lower limbs, DVT of the upper limb, and PE -- no bleeding component. The row carrying SELECT-D's data is a recurrent-VTE effect at 6 months. So one trial's endpoint counts a harm and the other two do not. This is not a neutral mismatch and its direction is known. Edoxaban caused more major bleeding than dalteparin, so including bleeding moves Hokusai from a recurrent-VTE hazard ratio of 0.71 to a composite of 0.97 -- the registry's own Cox analysis gives 0.97 (0.696 to 1.359). Pooling it with two efficacy-only endpoints mixes a harm signal into an efficacy estimate and drags the pool toward the null. Separately and sufficient on its own: one of the three trials is misidentified by registration. NCT02583191 is CONKO-011 (AIO-Studien-gGmbH, Germany, enrolment 246), whose registered primary is patient-reported treatment satisfaction measured to 4 weeks. The data on that row is SELECT-D's. See identity conflict on the trial. Separately again: the published number is not reconstructable from anything this page or this object holds. The index card served 'Published: HR 0.55 (0.30-1.00), k=4'. This object's pooled value is OR 0.7290 (0.4914 to 1.0817) at k=3. The page's own benchmark block holds 0.63 and 0.71 and no 0.55. Ten candidate pools of the page's own four published hazard ratios -- DerSimonian-Laird, REML and fixed-effect, each with Wald and Hartung-Knapp intervals, plus every three-trial subset -- give 0.60, 0.58, 0.64, 0.49, 0.54 and 0.75, and none gives 0.55 (0.30 to 1.00). The string '0.55' occurs on the page only inside CSS declarations and a chart legend position.1
outcomes[id=primary].name, results.by_outcome.primary.pooled.withdrawn_reasonnot recorded on the page this object was extracted from1
not recorded on the page this object was extracted from2
reconciliation.why_this_step_existsreconciliation.clean_becauseEligible trials that do not contribute: Adam VTE (NCT02585713) is counted in the index card's k=4 and contributes nothing to the pool, and nothing on the page says so. Its registered primary outcome is a rate, not a count -- 'The rate (percentage) of patients experiencing major bleeding at 6 months' -- and the registry reports it as 0 per cent of 145 against 2.1 per cent of 142. There are no event counts to have. This review derives every per-trial effect from 2x2 counts, so the trial drops out in silence and k falls from 4 to 3 with no surface saying so. This is the second topic in a row with this exact shape: on DOAC_AF it was rocket af. A count-derived pool silently excludes any trial whose registered primary is a rate, and the published k does not know it. Separately: the page carries publishedHR 0.26 (0.09-0.80) for this trial, which is a RECURRENT-VTE effect. Its registered primary is major bleeding. The number and the endpoint on this row are not the same endpoint.1
1 claim(s) previously made about this review were corrected and the corrections are retained on the object rather than overwritten.2
What this review does not give a clinician: the number of events in each arm, any absolute effect or number needed to treat and any measure of harm. A relative effect cannot be turned into the benefit or the risk facing one patient without them, so this review can support a judgement about what these trials found and not a judgement about what to do.3
eligible_but_not_contributing.noteclaims_correctedresults.by_outcomeThis review reports against PRISMA 2020. A screening record is held on this object and the flow it supports is shown in the Methods. The completed PRISMA checklist and FLOW diagram are not held here: the venue requires them deposited in an approved repository with a DOI cited in the Data Availability Statement, and minting that DOI is an author action rather than a build step.1
screeningNo PROSPERO registration or protocol record is held on this object. That is not the same as knowing this review was not registered, and neither claim is made. It is recorded here as an absence so that a reader does not have to infer it from silence.1
bookkeeping_2026_08_21.whether_this_review_was_prospectively_registered| Trial | Registration | Registry | Read |
|---|---|---|---|
| NCT02073682 | ClinicalTrials.gov | ||
| NCT02583191 | ClinicalTrials.gov | ||
| NCT03045406 | ClinicalTrials.gov |
| Cited for | Reference |
|---|---|
| the reporting guideline this manuscript is written against | Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71 |
manuscript.referencesmanuscript.references| Outcome | Figure | What it shows |
|---|---|---|
| Multiple trial-declared outcomes: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 6 Month Bleeding Rate | Recurrent Venous Thromboembolism | Forest plot | not pooled; the reason is given in Results |
results.by_outcomeresults.by_outcome.primary.per_trial, results.by_outcome.primary.pooledresults.by_outcome.primary.per_trial, results.by_outcome.primary.pooled| Registration | Trial | Participants | Randomised | Primary outcome measured over | Design |
|---|---|---|---|---|---|
| NCT02073682 | HOKUSAI VTE-Cancer | not recorded on the page this object was extracted from | 1046 | 12 months | Edoxaban group (treatment, n=522) vs Dalteparin group (control, n=524) [+2 further fields recorded on the object] |
| NCT02583191 | SELECT-D | not recorded on the page this object was extracted from | 246 | From randomization to 4 weeks after treatment start | Rivaroxaban (treatment, n=101) vs low-molecular heparine (control, n=102) [+2 further fields recorded on the object] |
| NCT03045406 | CARAVAGGIO | not recorded on the page this object was extracted from | 1170 | 6 months | Apixaban (treatment, n=576) vs Dalteparin (control, n=579) [+2 further fields recorded on the object] |
inputs.trialsOf the four properties this project requires of a completed topic, 0 are held (none) and 4 are refused with the obstacle named in the evidence (the number of published syntheses this review was a GRADE certainty rating for each pooled outcome, the statistical model's output, quoted as it was produced, a risk-of-bias judgement for each reported result).1
bookkeeping_2026_08_21.which_limbs_this_review_refusesThe items below were not written because the record does not hold what they would be composed from. They are named here so that an absence is not mistaken for an omission.
| Article area | Item not reported | Reason |
|---|---|---|
| Abstract | The Background sentence of the abstract | Background is argument -- why this question matters -- and no arrangement of the quantities this object holds yields it. It is emitted only from an authored field and there is no composition path for it here |
| Abstract | The Methods sentence of the abstract | None of the method facts this would be composed from -- databases searched, eligibility, pooling model, risk-of-bias tool, certainty approach -- is recorded on this object |
| Abstract | The Results sentence of the abstract -- no outcome on this object carries a pooled point estimate, so there is nothing to report and none is manufactured here | The reason each pool is declined is given in Results |
| Abstract | The Conclusions sentence of the abstract | A conclusion is argument -- what a reader should now believe -- and it is emitted only from an authored field. Composing one from the estimate would be this renderer telling the reader what to conclude, which no field supports |
| Keywords | The keyword list | A content gap; no keywords are recorded and inventing them would be indexing this review under terms nobody chose |
| Methods — search | A database search for primary trials, which was not carried out for this review; the included trials were identified from named registrations | No further reason is recorded. |
| Methods — how many studies at each stage | The k cascade | No further reason is recorded. |
| Methods — synthesis | The model/estimator sentence for multiple trial-declared outcomes: Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event | 6 Month Bleeding Rate | Recurrent Venous Thromboembolism | No pooled estimate was produced for this outcome, so no model was fitted and none is described |
| Methods — synthesis | The claim that records were screened in duplicate by two independent reviewers | No further reason is recorded. |
| Methods — synthesis | The claim that risk of bias was assessed with a named tool | No further reason is recorded. |
| Methods — synthesis | The claim that certainty of evidence was graded | No further reason is recorded. |
| Methods — synthesis | The claim that the review methods were prespecified before data collection | No further reason is recorded. |
| Risk of bias in the included results | The risk-of-bias assessment | No further reason is recorded. |
| Risk of bias in the included results | The risk-of-bias distribution | No further reason is recorded. |
| Certainty of the evidence | Certainty of the evidence, by outcome, with every rating step | No further reason is recorded. |
| Certainty of the evidence | The certainty assessment | No GRADE record is held, so the certainty column elsewhere on this page is an em dash rather than a guess |
| Discussion | The Discussion -- this is a content gap | The object records no interpretive text, and none is generated here: text written by the renderer would be an argument no field supports |
| Comparison with published syntheses | The comparison with published syntheses | No published synthesis is recorded for this topic, so no denominator can be given |
| Conclusions | The Conclusions -- this is a content gap | The object records no interpretive text, and none is generated here: text written by the renderer would be an argument no field supports |
| Data availability | The data availability statement | No further reason is recorded. |
| Software availability | The software and environment statement | No further reason is recorded. |
| Author contributions | The author-contributions statement | Who did what is a fact about people, and this object records none |
| Competing interests | The competing-interests declaration | F1000Research requires this section on every article, and requires explicit text where there is nothing to declare. It is a statement about the author and not about the evidence: no field of this object implies it and none is invented here |
| Grant information | The grant information | The venue requires each funder's name, the grant number where applicable, and the person the grant was assigned . None of that is derivable from a synthesis |
| Funding and conflicts of interest | The funding and conflict-of-interest statement -- a content gap | A submission requires it and this object does not carry it; it is not inferable from anything held here |
| Note on registration | The registration note | No further reason is recorded. |
| Registration | A registration statement: no prospective registration is recorded for this review, and whether one exists elsewhere has not been established | No further reason is recorded. |
| Extended data: statistical output, quoted verbatim | The verbatim model output | No analysis output is stored on this object, so nothing can be quoted and nothing is paraphrased in its place |
| Submission conformance | The submission conformance statement | No further reason is recorded. |
| Notes on this record — sections not written, and why | The list of refused properties | No further reason is recorded. |
UNSTAMPED — unknown-version. This page carries no build_stamp, so the standard it was built to cannot be established. That is a statement about the record, not a claim that the page is below standard.
Every number on this page is projected from a single canonical object, and each measured cell names the source analysis it was read from. That is what is machine-checked. It does not establish that the underlying sources are right, only that this page faithfully reports them.