Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (181 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 2016-11-30, after 2014-07-11 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 2016-11-30. 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) (raises risk) · Wording
Phrases that raised it: greatercreatininedlmmserum
Phrases that lowered it: pharmacokineticssubjectsmgperiod20 -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Phase: 3 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: quadruple (lowers risk) · Design
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Minimum age: 16 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 16 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 3 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- urogenital
- Drugs matched to FDA substances
- none matched
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
- KW-3357 Study in Patients With Early Onset Severe Preeclampsia NCT04182373 · started 2019 · scored riskier than 25% of active trials completed
- Study of Nicotinamide in Early Onset Preeclampsia NCT03419364 · started 2017 · scored riskier than 56% of active trials completed
- Aspirin to Prevent Preeclampsia in Women With Elevated Blood Pressure and Stage 1 Hypertension (ASPPIRE) NCT04402385 · started 2020 · scored riskier than 61% of active trials terminated
- Prevention of Maternal and Perinatal Complications by Enoxaparin in Women With Previous Severe Preeclampsia NCT00986765 · started 2009 · scored riskier than 36% of active trials completed
- A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor NCT02377466 · started 2016 · scored riskier than 64% of active trials terminated
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.