A Human AME Study for Omaveloxolone
Model scores of the 29,894 trials active now.
Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2019-05-31, after 2019-04-11 start.
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 2019-05-31. 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: enrollmentassesspriorsurgically18
Phrases that lowered it: absorptionhealthydrugthe pharmacokineticssubjects -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 18.0% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 32 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Blinding: none (lowers risk) · Design
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Maximum age: 55 (lowers risk) · Who can join
-
Responsible party: sponsor (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
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 7 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 255 (typical: 32)
- Sponsor's past termination rate
- 18.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 32 (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
- none of the 14 tracked areas
- Drugs matched to FDA substances
- omaveloxolone
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 Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers NCT03664453 · started 2018 · scored riskier than 2% of active trials completed
- A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone NCT04008186 · started 2019 · scored riskier than 3% of active trials completed
- An Open-label DDI Study of Omaveloxolone in Healthy Subjects NCT05909644 · started 2023 · scored riskier than 1% of active trials completed
- An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration NCT02274181 · started 2014 · scored riskier than 3% of active trials completed
- Evaluation of Metabolic Profile of OC000459 NCT02341521 · started 2015 · scored riskier than 2% 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.