A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis
Model scores of the 29,894 trials active now.
Model score 9% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (118 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-03-11, after 2018-10-18 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 2022-03-11. 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: tolerability pharmacokineticssafety tolerabilitystagelungdisorders
Phrases that lowered it: participantsscreeningevaluate thepharmacokineticsopen label -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 10.9% (raises risk) · Sponsor's track record
-
Phase: 1/2 (raises risk) · Design
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Drug's FAERS reports with a death: 32.5% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 9 (lowers risk) · Design
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Sponsor's past trials: 165 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 23 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 99.3% (raises risk) · Drug's FDA history
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Disease area, respiratory: Yes (raises risk) · Disease area
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Disease area, neurology: No (lowers risk) · Disease area
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Collaborators: 1 (raises 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
- 1/2 (typical: 2)
- Number of arms
- 9 (typical: 2)
- Allocation
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 64 (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
- 165 (typical: 32)
- Sponsor's past termination rate
- 10.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 23 (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
- 536 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 436 (typical: 412.5)
- Drug's FAERS reports marked serious
- 99.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 32.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, respiratory
- Drugs matched to FDA substances
- delamanid
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
- Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB NCT05221502 · started 2022 · scored riskier than 13% of active trials completed
- A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB) NCT00685360 · started 2008 · scored riskier than 6% of active trials completed
- A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683 NCT02573350 · started 2009 · scored riskier than 40% of active trials completed
- Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Meropenem Plus Amoxycillin/CA and Faropenem Plus Amoxycillin/CA in Adult Patients With Newly Diagnosed Pulmonary Tuberculosis NCT02349841 · started 2014 · scored riskier than 13% of active trials completed
- Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis NCT01131351 · started 2010 · scored riskier than 14% 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.