Comparison · NCT02573350-af95099e
Delamanid 100mg BID + OBR vs Delamanid 200mg BID + OBR: Number of Participants With Clinical Significant Abnormality in Thyroid Function Test Reported as TEAE
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. Delamanid 100mg BID + OBR vs Delamanid 200mg BID + OBR: Number of Participants With Clinical Significant Abnormality in Thyroid Function Test Reported as TEAE. Trial comparisons, record NCT02573350-af95099e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02573350-af95099e
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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 | 0.00000000000000000173 | 0.0273 | wilson | |
| Risk in group 2 | 0.0132 | 0.00233 | 0.0708 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0132 | -0.0708 | 0.0162 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Delamanid 100mg BID + OBR than on Delamanid 200mg BID + OBR | 76 | 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. | 0 | 137 | 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. | 1 | 76 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Clinical Significant Abnormality in Thyroid Function Test Reported as TEAE
- Description
Participants with abnormal thyroid free T4 nanograms per deciliter (ng/dL) and thyroid-stimulating hormone (\>=3 OR \<=0.3 micro-international units per litre (uIU/mL). An AE is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A TEAE is any new AE or worsening of an existing condition after initiation of study drug.
- Time frame
- From first dose through 28 days after last dose of study drug (up to approximately 30 weeks)
- Population
- Safety Population included all participants treated with at least one dose of Delamanid in this study.
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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