Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (389 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-01-25, after 2021-06-27 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2022-01-25. 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) (raises risk) · Wording
Phrases that raised it: patientpatientssurgerysurgicaldl
Phrases that lowered it: screeningopen labelacuteproductskg -
Sponsor's past termination rate: 20.2% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 48.3% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 38 (lowers risk) · Sponsor's track record
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Number of arms: not given (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Maximum age: 84 (lowers risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Collaborators: 0 (raises risk) · Design
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Keywords listed: 12 (lowers risk) · Design
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
- 2
- Number of arms
- not given (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 12 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 84 (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
- 109 (typical: 32)
- Sponsor's past termination rate
- 20.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 38 (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
- 263 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 106 (typical: 412.5)
- Drug's FAERS reports marked serious
- 87.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 48.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular
- Drugs matched to FDA substances
- andexanet alfa
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
- A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study) NCT02329327 · started 2015 · scored riskier than 76% of active trials completed
- Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor NCT04867837 · started 2021 · scored riskier than 47% of active trials terminated
- Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk. NCT02740335 · started 2017 · scored riskier than 85% of active trials completed
- Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures NCT00618098 · started 2008 · scored riskier than 93% of active trials completed
- Oral Apixaban (Eliquis) Versus Enoxaparin (Lovenox) for Thromboprophylaxis in Women With Suspected Pelvic Malignancy NCT02366871 · started 2015 · scored riskier than 61% 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.