Comparison · NCT02619994-sae
Experimental Arm vs Control Arm: 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. Experimental Arm vs Control Arm: serious adverse events. Trial comparisons, record NCT02619994-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02619994-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 | 0.253 | 0.17 | 0.359 | wilson | |
| Risk in group 2 | 0.213 | 0.141 | 0.31 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0397 | -0.0872 | 0.168 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.19 | 0.684 | 2.06 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.61 | 2.56 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Experimental Arm than on Control Arm | 25.2 | 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 | 20 | 79 | EG001 |
| 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 | 19 | 89 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All adverse events and serious adverse events were collected during the entire 24-month study period.
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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