Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
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 6% of the time (776 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 2011-05-31, after 2011-04-30 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 2011-05-31. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: determinetolerabilityqtcmedicationsdoses
Phrases that lowered it: bioequivalencetablethealthykgmg -
Design: crossover (lowers risk) · Design
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Sponsor's past termination rate: 15.6% (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 389 (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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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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Sponsor's past trials: 923 (raises risk) · Sponsor's track record
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Maximum age: 55 (lowers risk) · Who can join
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Drug's FAERS reports with a death: 17.5% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: none (lowers risk) · Design
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Disease area, psychiatry: No (lowers risk) · Disease area
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
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- 923 (typical: 32)
- Sponsor's past termination rate
- 15.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 389 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 2953 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 602 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- isoniazid, rifampin
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
- PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002) NCT02216331 · started 2010 · scored riskier than 1% of active trials completed
- TMC207 +/- Rifabutin/Rifampin NCT01341184 · started 2011 · scored riskier than 2% of active trials completed
- Drug-drug Interaction (DDI) Rifabutin NCT02138084 · started 2014 · scored riskier than 5% of active trials completed
- A Drug-drug Interaction Trial of Rifampicin Pharmacokinetics Effect on Fluzoparib NCT04011124 · started 2019 · scored riskier than 2% of active trials completed
- Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects NCT06592300 · started 2024 · scored riskier than 0% 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.