TriangleNCT05014412 · OUTCOME
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [All Causalities and Treatment Related]: Parts 1 and 2
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
- Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)
What was measured
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed below: Results in death, requires inpatient hospitalization or prolongation of existing hospitalization, life-threatening, congenital anomaly/birth defect etc. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.
Analysis population: Safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
Groups in this outcome
Part 1
Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 6 cycles. Thereafter, participants with PR or better response persisting for \>= 2 months on QW received 76 mg every Q2W and/or 116 mg or 152 mg Q4W from C7 and onwards. One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Part 2A: Dose Level 1
Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Part 2A: Dose Level 2
Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Part 2B
Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
| Group | Source count |
|---|---|
| Part 1 | 33 |
| Part 2A: Dose Level 1 | 12 |
| Part 2A: Dose Level 2 | 11 |
| Part 2B | 29 |
Reported measurements
All cause: AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 33 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 1 | 12 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 11 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 29 | Not reported | Not reported | Not reported | Not reported |
All cause: SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 23 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 1 | 11 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 8 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 21 | Not reported | Not reported | Not reported | Not reported |
Treatment related: AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 32 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 1 | 12 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 11 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 25 | Not reported | Not reported | Not reported | Not reported |
Treatment related: SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 17 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 1 | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 29
- title
- All cause: AE
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 21
- title
- All cause: SAE
- categories
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 25
- title
- Treatment related: AE
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- title
- Treatment related: SAE
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 29
- units
- Participants
- description
- An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed below: Results in death, requires inpatient hospitalization or prolongation of existing hospitalization, life-threatening, congenital anomaly/birth defect etc. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.
- groups
- description
- Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 6 cycles. Thereafter, participants with PR or better response persisting for \>= 2 months on QW received 76 mg every Q2W and/or 116 mg or 152 mg Q4W from C7 and onwards. One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
- id
- OG000
- title
- Part 1
- description
- Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
- id
- OG001
- title
- Part 2A: Dose Level 1
- description
- Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
- id
- OG002
- title
- Part 2A: Dose Level 2
- description
- Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
- id
- OG003
- title
- Part 2B
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
- reporting Status
- POSTED
- time Frame
- Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)
- title
- Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [All Causalities and Treatment Related]: Parts 1 and 2
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice