Essentiality of INH in TB Therapy
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (331 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2016-02-10, after 2015-06-30 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 2016-02-10. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Sponsor's past termination rate: 12% (raises risk) · Sponsor's track record
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: therapypriorkilltypecells
Phrases that lowered it: participantsartreceiptinfectedkg -
Drug's FAERS reports with a death: 17.1% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Number of arms: 4 (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 91.7% (raises risk) · Drug's FDA history
-
Blinding: none (raises risk) · Design
-
Collaborators: 1 (raises risk) · Design
-
Disease area, infectious disease: Yes (lowers risk) · Disease area
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Maximum age: not given (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
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 25 (typical: 32)
- Sponsor's past termination rate
- 12% (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
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 16762 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3926 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease
- Drugs matched to FDA substances
- ethambutol, isoniazid, moxifloxacin, pyrazinamide, 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
- Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002) NCT01498419 · started 2012 · scored riskier than 16% of active trials completed
- High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB) NCT01936831 · started 2014 · scored riskier than 34% of active trials completed
- The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB NCT02409290 · started 2016 · scored riskier than 39% of active trials completed
- Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis NCT05971602 · started 2023 · scored riskier than 25% of active trials terminated
- Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design NCT01785186 · started 2013 · scored riskier than 27% 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.