TriangleNCT03837509 · OUTCOME
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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 454 days
What was measured
A TEAE was defined as an adverse event (AE) that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Analysis population: Full Analysis Population: all participants enrolled in the study who received at least 1 dose of study treatment (INCB001158 or daratumumab subcutaneous \[SC\]). Participants were to be analyzed according to the treatment they were assigned to.
Groups in this outcome
Phase 1: INCB001158 75 mg BID + Daratumumab
In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
Phase 1: INCB001158 100 mg BID + Daratumumab
In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
| Group | Source count |
|---|---|
| Phase 1: INCB001158 75 mg BID + Daratumumab | 6 |
| Phase 1: INCB001158 100 mg BID + Daratumumab | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: INCB001158 75 mg BID + Daratumumab | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: INCB001158 100 mg BID + Daratumumab | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- A TEAE was defined as an adverse event (AE) that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
- groups
- description
- In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
- id
- OG000
- title
- Phase 1: INCB001158 75 mg BID + Daratumumab
- description
- In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.
- id
- OG001
- title
- Phase 1: INCB001158 100 mg BID + Daratumumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full Analysis Population: all participants enrolled in the study who received at least 1 dose of study treatment (INCB001158 or daratumumab subcutaneous \[SC\]). Participants were to be analyzed according to the treatment they were assigned to.
- reporting Status
- POSTED
- time Frame
- up to 454 days
- title
- Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice