Trial · NCT04489771
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 18 of 18
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Belzutifan 200 mg | 23.1 | 95% Confidence Interval 14.3 to 34.0 | Percentage of Participants | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Belzutifan 120 mg | 23.7 | 95% Confidence Interval 14.7 to 34.8 | Percentage of Participants | |
| Progression-Free Survival (PFS) According to RECIST 1.1 as Assessed by BICR | Belzutifan 200 mg | 9.1 | 95% Confidence Interval 5.5 to 12.0 | Months | |
| Progression-Free Survival (PFS) According to RECIST 1.1 as Assessed by BICR | Belzutifan 120 mg | 7.3 | 95% Confidence Interval 5.6 to 9.5 | Months | |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | Belzutifan 200 mg | 16.1 | 95% Confidence Interval 6.5 to NA | Months | |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | Belzutifan 120 mg | NA | 95% Confidence Interval 3.8 to NA | Months | |
| Clinical Benefit Rate (CBR) Per RECIST 1.1 as Assessed by BICR | Belzutifan 200 mg | 41.0 | 95% Confidence Interval 30.0 to 52.7 | Percentage of Participants | |
| Clinical Benefit Rate (CBR) Per RECIST 1.1 as Assessed by BICR | Belzutifan 120 mg | 47.4 | 95% Confidence Interval 35.8 to 59.2 | Percentage of Participants | |
| Overall Survival (OS) | Belzutifan 200 mg | NA | 95% Confidence Interval 20.6 to NA | Months | |
| Overall Survival (OS) | Belzutifan 120 mg | NA | 95% Confidence Interval 22.0 to NA | Months | |
| Number of Participants Who Experience One or More Adverse Events (AEs) | Belzutifan 200 mg | 77 | Number of Participants | ||
| Number of Participants Who Experience One or More Adverse Events (AEs) | Belzutifan 120 mg | 75 | Number of Participants | ||
| Number of Participants Who Discontinue Study Treatment Due to an AE | Belzutifan 200 mg | 11 | Number of Participants | ||
| Number of Participants Who Discontinue Study Treatment Due to an AE | Belzutifan 120 mg | 4 | Number of Participants | ||
| Maximum Plasma Concentration (Cmax) of Belzutifan | Belzutifan 200 mg | 2512 | Geometric Coefficient of Variation 86 | ng/mL | |
| Maximum Plasma Concentration (Cmax) of Belzutifan | Belzutifan 120 mg | 1518 | Geometric Coefficient of Variation 97 | ng/mL | |
| Trough Plasma Concentration (Ctrough) of Belzutifan | Belzutifan 200 mg | 513 | Geometric Coefficient of Variation 158 | ng/mL | |
| Trough Plasma Concentration (Ctrough) of Belzutifan | Belzutifan 120 mg | 296 | Geometric Coefficient of Variation 159 | ng/mL |
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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