Comparison · NCT01404312-sae
RPT Plus INH Regimen (Arm A) vs INH Regimen (Arm B): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. RPT Plus INH Regimen (Arm A) vs INH Regimen (Arm B): serious adverse events. Trial comparisons, record NCT01404312-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01404312-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0267 | 0.0197 | 0.0362 | wilson | |
| Risk in group 2 | 0.0452 | 0.0358 | 0.0569 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0185 | -0.0321 | -0.00514 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.591 | 0.403 | 0.868 | log | |
| Odds ratio, group 1 over group 2 | 0.58 | 0.39 | 0.863 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on RPT Plus INH Regimen (Arm A) than on INH Regimen (Arm B) | 54.1 | 31.1 | 195 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | RPT Plus INH Regimen (Arm A) | Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.~Rifapentine (RPT): RPT dosing was based on participants' weight:~Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).~Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).~Participants who weighed greater than 45 kg received 600 mg once daily (administered as four 150-mg tablets). | 40 | 1,496 | EG000 |
| Group 2 | INH Regimen (Arm B) | Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily~INH Regimen (Arm B) Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.~Isoniazid (INH): Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.~Pyridoxine (Vitamin B6): Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.~Participants receiving 25 mg of pyridoxine took one 25-mg tablet once daily with INH.~Participants receiving 50 mg of pyridoxine took two 25-mg tablets once daily with INH. | 68 | 1,504 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Source ClinicalTrials.gov
Trial
- Title
- Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)
- NCT number
- NCT01404312
- Phases
- PHASE3
- Conditions
- Tuberculosis, HIV Infections
- Interventions
- Rifapentine (RPT), Isoniazid (INH), Pyridoxine (Vitamin B6)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2018-12-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01404312?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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