TriangleNCT02431260 · OUTCOME
Number of Participants With a 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 30 days
What was measured
TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Analysis population: The safety population included all enrolled participants who received at least 1 dose of INCB054329.
Groups in this outcome
Part 1 / Treatment Group A: 15 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
Part 1 / Treatment Group A: 22.5 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
Part 1 / Treatment Group A: 15 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
Part 1 / Treatment Group A: 30 MG QD INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
Part 1 / Treatment Group A: 22.5 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
Part 1 / Treatment Group A: 20 MG BID INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
Part 1 / Treatment Group B: 20 MG BID INCB054329
Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
Part 2 / Treatment Group A: 20 MG BID INCB054329
Part 2 / treatment group A (TGA): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group A included any advanced solid tumor or lymphoma.
Part 2 / Treatment Group C: 20 mg BID INCB054329
Part 2 / treatment group C (TGC): dose titration was to determine the feasibility of intraparticipant dose titration using Protocol-defined criteria. Treatment Group C included multiple myeloma.
| Group | Source count |
|---|---|
| Part 1 / Treatment Group A: 15 MG QD INCB054329 | 4 |
| Part 1 / Treatment Group A: 22.5 MG QD INCB054329 | 5 |
| Part 1 / Treatment Group A: 15 MG BID INCB054329 | 6 |
| Part 1 / Treatment Group A: 30 MG QD INCB054329 | 5 |
| Part 1 / Treatment Group A: 22.5 MG BID INCB054329 | 3 |
| Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329 | 4 |
| Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329 | 4 |
| Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329 | 3 |
| Part 1 / Treatment Group A: 20 MG BID INCB054329 | 8 |
| Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329 | 8 |
| Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329 | 4 |
| Part 1 / Treatment Group B: 20 MG BID INCB054329 | 4 |
| Part 2 / Treatment Group A: 20 MG BID INCB054329 | 10 |
| Part 2 / Treatment Group C: 20 mg BID INCB054329 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 / Treatment Group A: 15 MG QD INCB054329 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1 / Treatment Group A: 22.5 MG QD INCB054329 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1 / Treatment Group A: 15 MG BID INCB054329 | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1 / Treatment Group A: 30 MG QD INCB054329 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1 / Treatment Group A: 22.5 MG BID INCB054329 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1 / Treatment Group A: 20 MG BID INCB054329 | 8 | Not reported | Not reported | Not reported | Not reported |
| Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329 | 8 | Not reported | Not reported | Not reported | Not reported |
| Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1 / Treatment Group B: 20 MG BID INCB054329 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 2 / Treatment Group A: 20 MG BID INCB054329 | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 2 / Treatment Group C: 20 mg BID INCB054329 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 8
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- units
- Participants
- description
- TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
- groups
- description
- Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
- id
- OG000
- title
- Part 1 / Treatment Group A: 15 MG QD INCB054329
- description
- Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
- id
- OG001
- title
- Part 1 / Treatment Group A: 22.5 MG QD INCB054329
- description
- Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
- id
- OG002
- title
- Part 1 / Treatment Group A: 15 MG BID INCB054329
- description
- Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
- id
- OG003
- title
- Part 1 / Treatment Group A: 30 MG QD INCB054329
- description
- Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
- id
- OG004
- title
- Part 1 / Treatment Group A: 22.5 MG BID INCB054329
- description
- Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
- id
- OG005
- title
- Part 1 / Treatment Group A: 22.5 MG BID 5/2 INCB054329
- description
- Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 4/3=4 days on/3 days off. Treatment Group A included any advanced solid tumor or lymphoma.
- id
- OG006
- title
- Part 1 / Treatment Group A: 22.5 MG BID 4/3 INCB054329
- description
- Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
- id
- OG007
- title
- Part 1 / Treatment Group A: 22.5 MG BID 7/7 INCB054329
- description
- Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. Treatment Group A included any advanced solid tumor or lymphoma.
- id
- OG008
- title
- Part 1 / Treatment Group A: 20 MG BID INCB054329
- description
- Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 5/2=5 days on/2 days off. Treatment Group A included any advanced solid tumor or lymphoma.
- id
- OG009
- title
- Part 1 / Treatment Group A: 25 MG BID 5/2 INCB054329
- description
- Part 1 / treatment group A (TGA): Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the TGA. 7/7=7 days on/7 days off. Treatment Group A included any advanced solid tumor or lymphoma.
- id
- OG010
- title
- Part 1 / Treatment Group A: 25 MG BID 7/7 INCB054329
- description
- Part 1 / treatment group B (TGB): Initial cohort dose of INCB054329 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included acute leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasms, or myelofibrosis.
- id
- OG011
- title
- Part 1 / Treatment Group B: 20 MG BID INCB054329
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety population included all enrolled participants who received at least 1 dose of INCB054329.
- reporting Status
- POSTED
- time Frame
- up to 30 days
- title
- Number of Participants With a 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