TriangleNCT04824794 · OUTCOME
Dose Escalation: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (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). In the RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1. As pre-specified, safety data were collected and are reported combined for both 0.2 and 0.6 mg/kg dose levels in this arm.
Groups in this outcome
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
RRMM Dose Escalation: GEN3014 2 mg/kg
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 4 mg/kg
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 8 mg/kg
Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 16 mg/kg
Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
RRMM Dose Escalation: GEN3014 24 mg/kg
Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
R/R AML Dose Escalation: GEN3014 Dose Level 1
Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
| Group | Source count |
|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 1 |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 1 |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 3 |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 3 |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 11 |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 5 |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 5 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 5 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 2 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 4 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 8 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 16 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| RRMM Dose Escalation: GEN3014 24 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| R/R AML Dose Escalation: GEN3014 Dose Level 1 | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 5
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 5
- 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 RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
- id
- OG000
- title
- RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG001
- title
- RRMM Dose Escalation: GEN3014 2 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG002
- title
- RRMM Dose Escalation: GEN3014 4 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG003
- title
- RRMM Dose Escalation: GEN3014 8 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG004
- title
- RRMM Dose Escalation: GEN3014 16 mg/kg
- description
- Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
- id
- OG005
- title
- RRMM Dose Escalation: GEN3014 24 mg/kg
- description
- Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
- id
- OG006
- title
- R/R AML Dose Escalation: GEN3014 Dose Level 1
- 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). In the RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg arm, the participant underwent intraparticipant dose escalation in Cycle 1. As pre-specified, safety data were collected and are reported combined for both 0.2 and 0.6 mg/kg dose levels in this arm.
- reporting Status
- POSTED
- time Frame
- Up to approximately 4 years 3 months
- title
- Dose Escalation: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice