Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 7% of the time (318 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2020-06-30, after 2013-01-10 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-06-30. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: bmscentralsurgerypediatricstable
Phrases that lowered it: single dosethe pharmacokineticsdruggastrointestinalabsorption -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Primary purpose: other (lowers risk) · Design
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Sponsor's past termination rate: 9.4% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 112 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 7 (lowers risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 16.3% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 96.2% (raises risk) · Drug's FDA history
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Sponsor's past trials: 363 (raises risk) · Sponsor's track record
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 7 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 0 (typical: 18)
- Maximum age
- 18 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 363 (typical: 32)
- Sponsor's past termination rate
- 9.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 112 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 208 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 24 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- apixaban
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter NCT01195727 · started 2011 · scored riskier than 14% of active trials terminated
- Study Evaluating Betrixaban in Pediatric Participants NCT03346083 · started 2018 · scored riskier than 28% of active trials terminated
- A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase NCT02369653 · started 2015 · scored riskier than 61% of active trials completed
- Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism NCT04041843 · started 2017 · scored riskier than 96% of active trials completed
- A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation NCT02981472 · started 2017 · scored riskier than 86% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.