TriangleNCT02903914 · OUTCOME
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 study completion (up to approximately 3.5 years)
What was measured
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study treatment(s). A TEAE was defined as any adverse event that started or worsened after the first dose of study drug.
Analysis population: Safety Population: all participants who received at least 1 dose of INCB001158 or pembrolizumab. Data collected through study completion have been reported.
Groups in this outcome
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
Part 1A: INCB001158 100 mg
INCB001158 administered orally at 100mg BID in participants with advanced/metastatic solid tumors.
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Part 1B: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
Part 1B: INCB001158 75 mg + Pembrolizumab
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
Part 1C: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
| Group | Source count |
|---|---|
| Part 1A: INCB001158 50 mg | 8 |
| Part 1A: INCB001158 75 mg | 7 |
| Part 1A: INCB001158 100 mg | 85 |
| Part 1A: INCB001158 150 mg | 7 |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 10 |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 14 |
| Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab | 123 |
| Part 1C: INCB001158 50 mg + Pembrolizumab | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: INCB001158 50 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 75 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 100 mg | 81 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 150 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 13 | Not reported | Not reported | Not reported | Not reported |
| Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab | 123 | Not reported | Not reported | Not reported | Not reported |
| Part 1C: INCB001158 50 mg + Pembrolizumab | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 81
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 123
- group Id
- OG007
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 85
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 123
- group Id
- OG007
- value
- 6
- units
- Participants
- description
- An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study treatment(s). A TEAE was defined as any adverse event that started or worsened after the first dose of study drug.
- groups
- description
- INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
- id
- OG000
- title
- Part 1A: INCB001158 50 mg
- description
- INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
- id
- OG001
- title
- Part 1A: INCB001158 75 mg
- description
- INCB001158 administered orally at 100mg BID in participants with advanced/metastatic solid tumors.
- id
- OG002
- title
- Part 1A: INCB001158 100 mg
- description
- INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
- id
- OG003
- title
- Part 1A: INCB001158 150 mg
- description
- INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
- id
- OG004
- title
- Part 1B: INCB001158 50 mg + Pembrolizumab
- description
- INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
- id
- OG005
- title
- Part 1B: INCB001158 75 mg + Pembrolizumab
- description
- INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
- id
- OG006
- title
- Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
- description
- INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg IV Q3W to participants with moderately impaired renal function.
- id
- OG007
- title
- Part 1C: INCB001158 50 mg + Pembrolizumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population: all participants who received at least 1 dose of INCB001158 or pembrolizumab. Data collected through study completion have been reported.
- reporting Status
- POSTED
- time Frame
- up to study completion (up to approximately 3.5 years)
- title
- 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