Comparison · NCT02153528-7b4fc3fb
Standard TB Treatment vs Double Rimfampicin: Number of Participants Who Develop Liver Toxicity
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Standard TB Treatment vs Double Rimfampicin: Number of Participants Who Develop Liver Toxicity. Trial comparisons, record NCT02153528-7b4fc3fb. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02153528-7b4fc3fb
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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 | 0.0204 | 0.00992 | 0.0415 | wilson | |
| Risk in group 2 | 0.00857 | 0.00292 | 0.0249 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0118 | -0.00756 | 0.0337 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.38 | 0.621 | 9.13 | log | |
| Odds ratio, group 1 over group 2 | 2.41 | 0.618 | 9.4 | log | |
| Number needed to treat, for one more participant with the outcome on Standard TB Treatment than on Double Rimfampicin | 84.5 | from the risk difference interval | the interval includes no difference |
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 | Standard TB Treatment | Standard regimen for TB treatment according to guidelines of the International Union against Tuberculosis and Lung Disease~Standard TB treatment: Standard regimen for TB treatment according to guidelines of the International Union against Tuberculosis and Lung Disease | 7 | 343 | OG000 |
| Group 2 | Double Rimfampicin | 2HREZ/4HR Cat. 1, modified by using double dose rifampicin throughout~double rimfampicin: Compared to standard regimen dosing of rifampicin is doubled, while standard dose isoniazid, pyrazinamide and ethambutol are maintained | 3 | 350 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Develop Liver Toxicity
- Description
- Grade 3-4 Liver Toxicity following NIH common toxicity criteria (CTC), including transaminase increases to \>5-20 ULN (grade 3), or \> 20 ULN (grade 4)
- Time frame
- until month eight
- Population
One participant was allocated to double rifampicin arm but received standard TB treatment, and was analysed in the standard TB treatment arm.Two participants were deleted from analysis because they had grade 3 liver toxicity at baseline and 6 participants were deleted because they did not have any follow-up ALT values.
Source ClinicalTrials.gov
Trial
- Title
- Optimization of the TB Treatment Regimen Cascade
- NCT number
- NCT02153528
- Phases
- PHASE3
- Conditions
- Tuberculosis, Pulmonary
- Interventions
- double rimfampicin, Standard TB treatment
- Lead sponsor
- Damien Foundation
- Results first posted
- 2020-02-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02153528?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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