TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.
Model scores of the 29,894 trials active now.
Model score 3% 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 2009-11-30, after 2008-06-30 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 2009-11-30. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: carcinomadiseasetolerabilityfunctionsubjects with
Phrases that lowered it: healthytrialmoderatedrugthe pharmacokinetics -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Primary purpose: not given (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Sponsor's past termination rate: 9.1% (raises risk) · Sponsor's track record
-
Responsible party: not given (raises risk) · Design
-
Number of arms: not given (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 9 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Blinding: none (lowers risk) · Design
-
Sponsor's past trials: 11 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Maximum age: 65 (lowers risk) · Who can join
-
Disease area, psychiatry: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
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
- not given (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- not given (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 11 (typical: 32)
- Sponsor's past termination rate
- 9.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- infectious disease, immunology, urogenital
- Drugs matched to FDA substances
- rilpivirine
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 of TMC207 in Patients With Moderately Impaired Hepatic Function NCT01012284 · started 2010 · scored riskier than 3% of active trials completed
- TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435 NCT01046058 · started 2010 · scored riskier than 4% of active trials completed
- A Clinical Study to Access the Pharmacokinetics of HMS5552 in Hepatic Impaired Subjects and Healthy Volunteers NCT04426708 · started 2019 · scored riskier than 1% of active trials completed
- Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function NCT01923870 · started 2013 · scored riskier than 7% of active trials completed
- A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031) NCT01767688 · started 2013 · scored riskier than 3% 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.