Trial · NCT04589650
Results by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 132
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants Randomized to Alpelisib With a Confirmed Objective Response by BIRC in Group 1 and Group 2 | Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm | 16.7 | 97.5% Confidence Interval 7.0 to 31.1 | % of confirmed responder by BIRC | |
| Proportion of Participants Randomized to Alpelisib With a Confirmed Objective Response by BIRC in Group 1 and Group 2 | Group 2 (6-17 Years) - Alpelisib Arm | 23.2 | 97.5% Confidence Interval 11.9 to 38.3 | % of confirmed responder by BIRC | |
| Key Secondary Objective: Proportion of Participants With Response at Week 16 by BIRC in Group 1 and Group 2 | Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm | 11.1 | 95% Confidence Interval 4.2 to 22.6 | % of responder by BIRC | |
| Key Secondary Objective: Proportion of Participants With Response at Week 16 by BIRC in Group 1 and Group 2 | Group 1 (Greater or Equal to 18 Years) - Placebo Arm | 0 | 95% Confidence Interval 0.0 to 12.8 | % of responder by BIRC | |
| Key Secondary Objective: Proportion of Participants With Response at Week 16 by BIRC in Group 1 and Group 2 | Group 2 (6-17 Years) - Alpelisib Arm | 8.9 | 95% Confidence Interval 3.0 to 19.6 | % of responder by BIRC | |
| Key Secondary Objective: Proportion of Participants With Response at Week 16 by BIRC in Group 1 and Group 2 | Group 2 (6-17 Years) - Placebo Arm | 0 | 95% Confidence Interval 0.0 to 12.3 | % of responder by BIRC | |
| Proportion of Participants With a Response at Week 24 (by BIRC) in Groups 1 and 2 | Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm | 16.7 | 97.5% Confidence Interval 7 to 31.1 | % of confirmed responder by BIRC | |
| Proportion of Participants With a Response at Week 24 (by BIRC) in Groups 1 and 2 | Group 2 (6-17 Years) - Alpelisib Arm | 19.6 | 97.5% Confidence Interval 9.2 to 34.3 | % of confirmed responder by BIRC | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm | Adverse Events (AEs) | 50 | Participants | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 1 (Greater or Equal to 18 Years) - Placebo Arm | Adverse Events (AEs) | 26 | Participants | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 2 (6-17 Years) - Alpelisib Arm | Adverse Events (AEs) | 50 | Participants | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 2 (6-17 Years) - Placebo Arm | Adverse Events (AEs) | 24 | Participants | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm | Treatment-related AEs | 31 | Participants | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 1 (Greater or Equal to 18 Years) - Placebo Arm | Treatment-related AEs | 12 | Participants | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 2 (6-17 Years) - Alpelisib Arm | Treatment-related AEs | 19 | Participants | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 2 (6-17 Years) - Placebo Arm | Treatment-related AEs | 9 | Participants | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 1 (Greater or Equal to 18 Years) - Alpelisib Arm | AEs with grade >=3 | 11 | Participants | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 1 (Greater or Equal to 18 Years) - Placebo Arm | AEs with grade >=3 | 5 | Participants | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 2 (6-17 Years) - Alpelisib Arm | AEs with grade >=3 | 7 | Participants | |
| Frequency and Severity of Adverse Events in Groups 1 and 2 up to Week 16 | Group 2 (6-17 Years) - Placebo Arm | AEs with grade >=3 | 2 | Participants |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT04589650/results