Comparison · NCT02573350-d461de93
Delamanid 100mg BID + OBR vs Delamanid 200mg BID + OBR: Number of Participants With Clinical Significant Abnormality in Cortisol
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. Delamanid 100mg BID + OBR vs Delamanid 200mg BID + OBR: Number of Participants With Clinical Significant Abnormality in Cortisol. Trial comparisons, record NCT02573350-d461de93. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02573350-d461de93
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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 | 0.324 | 0.251 | 0.406 | wilson | |
| Risk in group 2 | 0.25 | 0.166 | 0.358 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0735 | -0.0565 | 0.191 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.29 | 0.818 | 2.05 | log | |
| Odds ratio, group 1 over group 2 | 1.43 | 0.763 | 2.7 | log | |
| Number needed to treat, for one more participant with the outcome on Delamanid 100mg BID + OBR than on Delamanid 200mg BID + OBR | 13.6 | 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 | Delamanid 100mg BID + OBR | Participants received Delamanid 100 mg (2x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR from Week 0 to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. | 44 | 136 | OG000 |
| Group 2 | Delamanid 200mg BID + OBR | Participants received Delamanid 200 mg (4x50 mg tablets), orally, BID along with at least 4 additional anti-TB medications per OBR up to Week 26. Participants were administered OBR as directed by the given investigator based on WHO guidelines and clinical judgment. A participant might have been titrated to Delamanid 200 mg BID after an initial hospitalization of 2 weeks. Participants were grouped according to the longest duration of Delamanid dose administered during the study. | 19 | 76 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Clinical Significant Abnormality in Cortisol
- Description
- Participants with clinically significant cortisol \>=26 micrograms/decilitre (ug/dL) were reported.
- Time frame
- From first dose of study drug up to Week 26
- Population
Safety Population included all participants treated with at least one dose of Delamanid in this study. Overall number of participants analyzed is the number of participants with at least one post-baseline result for the given test.
Source ClinicalTrials.gov
Trial
- Title
- A Trial to Evaluate Safety, Tolerability, and Efficacy of Orally Administered OPC-67683
- NCT number
- NCT02573350
- Phases
- PHASE2
- Conditions
- Tuberculosis, Multidrug-Resistant
- Interventions
- Delamanid, OBR
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Results first posted
- 2021-11-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02573350?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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