TriangleNCT04776018 · OUTCOME
Phase 2: Number of Participants With TEAEs and TEAEs by Severity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to 24 months
What was measured
TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. The severity grade was evaluated as per the NCI CTCAE Version 5.0, except for CRS, which was assessed by ASTCT consensus grading. Where Grade 3 was severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4 was 4 Life-threatening consequences; urgent intervention indicated. and Grade 5 was death related to AE. TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.
Analysis population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.
Groups in this outcome
Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody
Participants were planned to receive TAK-981 recommended phase 2 dose (RP2D), infusion, intravenously, in combination with an anti-CD38 antibody (mezagitamab or daratumumab and hyaluronidase-fihj), injection, subcutaneously, for up to 24 cycles or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
| Group | Source count |
|---|---|
| Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. The severity grade was evaluated as per the NCI CTCAE Version 5.0, except for CRS, which was assessed by ASTCT consensus grading. Where Grade 3 was severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4 was 4 Life-threatening consequences; urgent intervention indicated. and Grade 5 was death related to AE. TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.
- groups
- description
- Participants were planned to receive TAK-981 recommended phase 2 dose (RP2D), infusion, intravenously, in combination with an anti-CD38 antibody (mezagitamab or daratumumab and hyaluronidase-fihj), injection, subcutaneously, for up to 24 cycles or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
- id
- OG000
- title
- Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody
- population Description
- The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.
- reporting Status
- POSTED
- time Frame
- Up to 24 months
- title
- Phase 2: Number of Participants With TEAEs and TEAEs by Severity
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice