Comparison · NCT02697734-da959919
Osilodrostat Group vs Osilodrostat Placebo Group: Percentage of Randomized Participants With a Complete Response
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. Osilodrostat Group vs Osilodrostat Placebo Group: Percentage of Randomized Participants With a Complete Response. Trial comparisons, record NCT02697734-da959919. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02697734-da959919
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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 | 0.771 | 0.635 | 0.867 | wilson | |
| Risk in group 2 | 0.08 | 0.0222 | 0.25 | wilson | |
| Risk difference, group 1 minus group 2 | 0.691 | 0.473 | 0.803 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 9.64 | 2.53 | 36.7 | log | |
| Odds ratio, group 1 over group 2 | 38.7 | 7.86 | 190 | log | |
| Number needed to treat, for one more participant with the outcome on Osilodrostat Group than on Osilodrostat Placebo Group | 1.45 | 1.25 | 2.11 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Osilodrostat Group | Participants in this arm were randomized to receive the study drug, osilodrostat, followed after Week 12 by open-label osilodrostat at the starting dose (with a second dose titration). | 37 | 48 | OG000 |
| Group 2 | Osilodrostat Placebo Group | Participants in this arm were randomized to receive osilodrostat placebo followed after Week 12 by open-label osilodrostat at the starting dose (with a dose titration). | 2 | 25 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Percentage of Randomized Participants With a Complete Response
- Description
A complete responder at week 12 is defined as a participant who had a mean urine free cortisol ≤ upper limit of normal (mUFC ≤ ULN) at Week 12.~Participants who had a missing mUFC assessment at Week 12 were counted as non-responders for the primary endpoint.
- Time frame
- at Week 12
- Population
- Full Analysis Set: comprises all randomized participants who received at least one dose of study drug (osilodrostat or placebo)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease
- NCT number
- NCT02697734
- Phases
- PHASE3
- Conditions
- Cushing's Disease
- Interventions
- osilodrostat, osilodrostat Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2021-10-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02697734?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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