Comparison · NCT01380080-sae
Arm A: Empiric vs Arm B: IPT: serious adverse events
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. Arm A: Empiric vs Arm B: IPT: serious adverse events. Trial comparisons, record NCT01380080-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01380080-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 | 0.2 | 0.165 | 0.241 | wilson | |
| Risk in group 2 | 0.221 | 0.184 | 0.262 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0202 | -0.0749 | 0.0347 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.909 | 0.7 | 1.18 | log | |
| Odds ratio, group 1 over group 2 | 0.886 | 0.637 | 1.23 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A: Empiric than on Arm B: IPT | 49.5 | 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 | Arm A: Empiric | Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only | 85 | 424 | EG000 |
| Group 2 | Arm B: IPT | Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH). | 94 | 426 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From treatment dispensation to up to week 96
Source ClinicalTrials.gov
Trial
- Title
- REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment
- NCT number
- NCT01380080
- Phases
- PHASE4
- Conditions
- HIV Infection
- Interventions
- Atripla (r), Efavirenz, Truvada, Rifampin/isoniazid/pyrazinamide/ethambutol FDC, Rifampin/isoniazid FDC, Isoniazid
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Results first posted
- 2016-02-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01380080?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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