Comparison · NCT02619994-ff16805d
Experimental Arm vs Control Arm: Treatment Success Rate
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. Experimental Arm vs Control Arm: Treatment Success Rate. Trial comparisons, record NCT02619994-ff16805d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02619994-ff16805d
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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 | 0.75 | 0.639 | 0.836 | wilson | |
| Risk in group 2 | 0.706 | 0.602 | 0.792 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0441 | -0.0964 | 0.179 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.877 | 1.29 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.615 | 2.54 | log | |
| Number needed to treat, for one more participant with the outcome on Experimental Arm than on Control Arm | 22.7 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Experimental Arm | Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.~* Delamanid (100 mg bid for the entire treatment period)~* Linezolid (600mg/day for 2 months and 300mg/day afterwards until the end of treatment)~* Levofloxacin (750 \~1000 mg/day)~* Pyrazinamide (1000\~ 2000 mg/day)~Linezolid~Delamanid~Levofloxacin~Pyrazinamide | 54 | 72 | OG001 |
| Group 2 | Control Arm | Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.~* Intensive phase regimen consists of four effective second-line anti-TB drugs (including injectables) and pyrazinamide.~* Treatment duration: for at least 20 months~Locally-used WHO-approved MDR-TB regimen in Korea | 60 | 85 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Treatment Success Rate
- Description
To test for non-inferiority of the investigational arm, when the lower limit of the one-sided 97.5% confidence interval of the difference (PT - PC) between investigational and control arms is larger than the non-inferiority margin of - 10%, it will be concluded that the treatment success rate of the investigational arm shows non-inferiority to the treatment success rate of the control arm.~(primary consideration for the modified intention-to-treat results)
- Time frame
- 24 months after treatment start
- Population
- mITT population Participant with \[not assessable\] was not included in the analysis
Source ClinicalTrials.gov
Trial
- Title
- Treatment Shortening of MDR-TB Using Existing and New Drugs
- NCT number
- NCT02619994
- Phases
- PHASE2
- Conditions
- Tuberculosis, Multidrug-Resistant
- Interventions
- Linezolid, Delamanid, Levofloxacin, Pyrazinamide, Locally-used WHO-approved MDR-TB regimen in Korea
- Lead sponsor
- Seoul National University Hospital
- Results first posted
- 2025-01-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02619994?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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