Trial · NCT04304144
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 31
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | DLT Period (Part A): CAEL-101 500 mg/m^2 | Any TEAEs | 4 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | DLT Period (Part A): CAEL-101 750 mg/m^2 | Any TEAEs | 3 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | DLT Period (Part A): CAEL-101 1000 mg/m^2 | Any TEAEs | 6 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD | Any TEAEs | 13 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab | Any TEAEs | 12 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | DLT Period (Part A): CAEL-101 500 mg/m^2 | Treatment-emergent SAEs | 0 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | DLT Period (Part A): CAEL-101 750 mg/m^2 | Treatment-emergent SAEs | 0 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | DLT Period (Part A): CAEL-101 1000 mg/m^2 | Treatment-emergent SAEs | 2 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD | Treatment-emergent SAEs | 9 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab | Treatment-emergent SAEs | 7 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | DLT Period (Part A): CAEL-101 500 mg/m^2 | AEs Leading to Treatment Discontinuation | 0 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | DLT Period (Part A): CAEL-101 750 mg/m^2 | AEs Leading to Treatment Discontinuation | 0 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | DLT Period (Part A): CAEL-101 1000 mg/m^2 | AEs Leading to Treatment Discontinuation | 0 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD | AEs Leading to Treatment Discontinuation | 3 | Participants | |
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation | Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab | AEs Leading to Treatment Discontinuation | 1 | Participants | |
| Number of Participants With Dose-limiting Toxicity (DLT) During the First 4 Weeks of Therapy | Part A: CAEL-101 500 mg/m^2 Combined With SoC CyBorD | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicity (DLT) During the First 4 Weeks of Therapy | Part A: CAEL-101 750 mg/m^2 Combined With SoC CyBorD | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicity (DLT) During the First 4 Weeks of Therapy | Part A: CAEL-101 1000 mg/m^2 Combined With SoC CyBorD | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicity (DLT) During the First 4 Weeks of Therapy | Part B: CAEL-101 Combined With SoC CyBorD and Daratumumab | 0 | Participants | ||
| Maximum Observed Plasma Concentration (Cmax) of CAEL-101 | Part A: CAEL-101 500 mg/m^2 | Week 1 | 126 | Standard Deviation 16.7 | micrograms (µg)/milliliter (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.
For software
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