9INH vs 3RPT/INH: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0271 | 0.0224 | 0.0328 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0149 | 0.0116 | 0.0191 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0123 | 0.00595 | 0.0189 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.83 | 1.33 | 2.51 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.85 | 1.34 | 2.55 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on 9INH than on 3RPT/INH | 81.4 | 53 | 168 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | 9INH | Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent \[within 2 years\] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses). | 102 | 3,759 | EG000 | ClinicalTrials.gov |
| Group 2 | 3RPT/INH | Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent \[within 2 years\] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH. | 60 | 4,040 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Baseline until Month 35 | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection | ClinicalTrials.gov |
| NCT number | NCT00023452 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Tuberculosis | ClinicalTrials.gov |
| Interventions | RPT + INH once weekly for 3 months given by DOT, Isoniazid (INH) daily for 9 months | ClinicalTrials.gov |
| Lead sponsor | Centers for Disease Control and Prevention | ClinicalTrials.gov |
| Results first posted | 2012-09-27 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00023452?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.