TriangleNCT04304144 · OUTCOME
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- First dose of study drug until 140 days after last dose of study drug (Maximum exposure: 38.90 months for Part A and 32.50 months for Part B)
What was measured
An adverse event (AE) was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), or an important medical event or reaction. A TEAE was defined as an AE that started after the first dose of treatment and before the last dose of study drug +140 days. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Analysis population: Safety Set included all participants who were treated with at least 1 dose of CAEL-101. AE data were collected for the participants in the DLT period (Part A) by dose separately. Additionally, the AE data for participants in the DLT period were also collected regardless of dose level received along with the AE data collected during the Part A Continued Treatment (Part A) period as an Overall arm.
Groups in this outcome
DLT Period (Part A): CAEL-101 500 mg/m^2
Participants received CAEL-101 500 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).
DLT Period (Part A): CAEL-101 750 mg/m^2
Participants received CAEL-101 750 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).
DLT Period (Part A): CAEL-101 1000 mg/m^2
Participants received CAEL-101 1000 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).
Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD
Participants received CAEL-101 during the DLT period weekly as an IV infusion the first 4 weeks, and thereafter received CAEL-101 at the RP3D (1000 mg/m\^2) every other week until the end of study, in combination with the SoC CyBorD (cyclophosphamide, bortezomib, dexamethasone) chemotherapy.
Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab
Participants received CAEL-101 at the RP3D (1000 mg/m\^2) administered weekly as an IV infusion for the first 4 weeks, and then every other week until end of study, in combination with the SoC CyBorD chemotherapy and daratumumab.
| Group | Source count |
|---|---|
| DLT Period (Part A): CAEL-101 500 mg/m^2 | 4 |
| DLT Period (Part A): CAEL-101 750 mg/m^2 | 3 |
| DLT Period (Part A): CAEL-101 1000 mg/m^2 | 6 |
| Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD | 13 |
| Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab | 12 |
Reported measurements
Any TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DLT Period (Part A): CAEL-101 500 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| DLT Period (Part A): CAEL-101 750 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| DLT Period (Part A): CAEL-101 1000 mg/m^2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD | 13 | Not reported | Not reported | Not reported | Not reported |
| Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab | 12 | Not reported | Not reported | Not reported | Not reported |
Treatment-emergent SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DLT Period (Part A): CAEL-101 500 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| DLT Period (Part A): CAEL-101 750 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| DLT Period (Part A): CAEL-101 1000 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD | 9 | Not reported | Not reported | Not reported | Not reported |
| Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab | 7 | Not reported | Not reported | Not reported | Not reported |
AEs Leading to Treatment Discontinuation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DLT Period (Part A): CAEL-101 500 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| DLT Period (Part A): CAEL-101 750 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| DLT Period (Part A): CAEL-101 1000 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD | 3 | Not reported | Not reported | Not reported | Not reported |
| Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 12
- title
- Any TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 7
- title
- Treatment-emergent SAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- title
- AEs Leading to Treatment Discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 12
- units
- Participants
- description
- An adverse event (AE) was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), or an important medical event or reaction. A TEAE was defined as an AE that started after the first dose of treatment and before the last dose of study drug +140 days. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
- groups
- description
- Participants received CAEL-101 500 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).
- id
- OG000
- title
- DLT Period (Part A): CAEL-101 500 mg/m^2
- description
- Participants received CAEL-101 750 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).
- id
- OG001
- title
- DLT Period (Part A): CAEL-101 750 mg/m^2
- description
- Participants received CAEL-101 1000 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period).
- id
- OG002
- title
- DLT Period (Part A): CAEL-101 1000 mg/m^2
- description
- Participants received CAEL-101 during the DLT period weekly as an IV infusion the first 4 weeks, and thereafter received CAEL-101 at the RP3D (1000 mg/m\^2) every other week until the end of study, in combination with the SoC CyBorD (cyclophosphamide, bortezomib, dexamethasone) chemotherapy.
- id
- OG003
- title
- Overall (Part A): DLT + Continued Treatment Period: CAEL-101 Combined With SoC CyBorD
- description
- Participants received CAEL-101 at the RP3D (1000 mg/m\^2) administered weekly as an IV infusion for the first 4 weeks, and then every other week until end of study, in combination with the SoC CyBorD chemotherapy and daratumumab.
- id
- OG004
- title
- Continued Treatment Period (Part B): CAEL-101 Combined With SoC CyBorD and Daratumumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Set included all participants who were treated with at least 1 dose of CAEL-101. AE data were collected for the participants in the DLT period (Part A) by dose separately. Additionally, the AE data for participants in the DLT period were also collected regardless of dose level received along with the AE data collected during the Part A Continued Treatment (Part A) period as an Overall arm.
- reporting Status
- POSTED
- time Frame
- First dose of study drug until 140 days after last dose of study drug (Maximum exposure: 38.90 months for Part A and 32.50 months for Part B)
- title
- Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Adverse Events (AEs), and AEs Leading to Treatment Discontinuation
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice