TriangleNCT04824794 · OUTCOME
Expansion Part A and Part B: Number of Participants With AEs and SAEs
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
- Up to approximately 4 years 3 months
What was measured
An AE was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE was defined as an AE that met 1 of the following criteria: fatal or life-threatening, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, was medically significant (jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above), required inpatient hospitalization or prolongation of existing hospitalization. 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 Analysis Set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC).
Groups in this outcome
RRMM Expansion Part A: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
R/R DLBCL Expansion Part A: GEN3014
Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
RRMM Expansion Part B: Daratumumab
Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
RRMM Expansion Part B: GEN3014
Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
| Group | Source count |
|---|---|
| RRMM Expansion Part A: GEN3014 | 11 |
| R/R DLBCL Expansion Part A: GEN3014 | 2 |
| RRMM Expansion Part B: Daratumumab | 43 |
| RRMM Expansion Part B: GEN3014 | 45 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Expansion Part A: GEN3014 | 9 | Not reported | Not reported | Not reported | Not reported |
| R/R DLBCL Expansion Part A: GEN3014 | 2 | Not reported | Not reported | Not reported | Not reported |
| RRMM Expansion Part B: Daratumumab | 36 | Not reported | Not reported | Not reported | Not reported |
| RRMM Expansion Part B: GEN3014 | 45 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Expansion Part A: GEN3014 | 6 | Not reported | Not reported | Not reported | Not reported |
| R/R DLBCL Expansion Part A: GEN3014 | 1 | Not reported | Not reported | Not reported | Not reported |
| RRMM Expansion Part B: Daratumumab | 11 | Not reported | Not reported | Not reported | Not reported |
| RRMM Expansion Part B: GEN3014 | 19 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 36
- group Id
- OG003
- value
- 45
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 19
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 43
- group Id
- OG003
- value
- 45
- units
- Participants
- description
- An AE was any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE was defined as an AE that met 1 of the following criteria: fatal or life-threatening, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, was medically significant (jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above), required inpatient hospitalization or prolongation of existing hospitalization. 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 with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
- id
- OG000
- title
- RRMM Expansion Part A: GEN3014
- description
- Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
- id
- OG001
- title
- R/R DLBCL Expansion Part A: GEN3014
- description
- Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
- id
- OG002
- title
- RRMM Expansion Part B: Daratumumab
- description
- Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
- id
- OG003
- title
- RRMM Expansion Part B: GEN3014
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC).
- reporting Status
- POSTED
- time Frame
- Up to approximately 4 years 3 months
- title
- Expansion Part A and Part B: Number of Participants With AEs and SAEs
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice