TriangleNCT05014412 · OUTCOME
Number of Participants With Maximum Grade 3 or 4 and Grade 5 AEs [All Causalities and Treatment Related] Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5: 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 was 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. 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. AEs were graded according to NCI CTCAE version 5.0 as Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated. Grade 5 indicates death related to AE.
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: Grades 3/4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 26 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 20 | Not reported | Not reported | Not reported | Not reported |
All cause: Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 5 | Not reported | Not reported | Not reported | Not reported |
Treatment related: Grades 3/4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 23 | 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 | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 16 | Not reported | Not reported | Not reported | Not reported |
Treatment related: Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 20
- title
- All cause: Grades 3/4
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- title
- All cause: Grade 5
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 16
- title
- Treatment related: Grades 3/4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Treatment related: Grade 5
- 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 was 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. 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. AEs were graded according to NCI CTCAE version 5.0 as Grade 1 indicates Mild AE, Grade 2 indicates Moderate AE, Grade 3 indicates severe AE, and grade 4 indicates life-threatening consequences; urgent intervention indicated. Grade 5 indicates death related to AE.
- 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 Maximum Grade 3 or 4 and Grade 5 AEs [All Causalities and Treatment Related] Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5: Parts 1 and 2
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice