Comparison · NCT02697734-cf57f418
Osilodrostat Group vs Osilodrostat Placebo Group: Time-to-first Control of mUFC - Number (%) of Participants With mUFC <=ULN
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: Time-to-first Control of mUFC - Number (%) of Participants With mUFC <=ULN. Trial comparisons, record NCT02697734-cf57f418. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02697734-cf57f418
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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 | 0.938 | 0.832 | 0.979 | wilson | |
| Risk in group 2 | 0.32 | 0.172 | 0.516 | wilson | |
| Risk difference, group 1 minus group 2 | 0.617 | 0.395 | 0.771 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.93 | 1.65 | 5.21 | log | |
| Odds ratio, group 1 over group 2 | 31.9 | 7.56 | 134 | log | |
| Number needed to treat, for one more participant with the outcome on Osilodrostat Group than on Osilodrostat Placebo Group | 1.62 | 1.3 | 2.53 | 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). | 45 | 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). | 8 | 25 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Time-to-first Control of mUFC - Number (%) of Participants With mUFC <=ULN
- Description
To assess time-to-first control of mUFC, (in days) from randomization to the first mUFC collection that was ≤ ULN before completion/discontinuation of placebo-controlled period.~Participants who did not achieve post-baseline mUFC control were censored at discontinuation or completion of placebo-controlled period, whichever was earlier.
- Time frame
- up to 12 weeks
- 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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