TriangleNCT02923349 · OUTCOME
Number of Participants With Treatment-related Adverse Events
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
- From screening through 60 days after end of treatment, up to 11 months
What was measured
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Analysis population: The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
Groups in this outcome
PART 1 Dose 1 (7 mg)
INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 2 (20 mg)
INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 3 (70 mg)
INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 4 (200 mg)
INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 5 (350 mg)
INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 6 (700 mg)
INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
PART 1 Dose 7 (1400 mg)
INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
| Group | Source count |
|---|---|
| PART 1 Dose 1 (7 mg) | 4 |
| PART 1 Dose 2 (20 mg) | 4 |
| PART 1 Dose 3 (70 mg) | 22 |
| PART 1 Dose 4 (200 mg) | 18 |
| PART 1 Dose 5 (350 mg) | 23 |
| PART 1 Dose 6 (700 mg) | 12 |
| PART 1 Dose 7 (1400 mg) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PART 1 Dose 1 (7 mg) | 4 | Not reported | Not reported | Not reported | Not reported |
| PART 1 Dose 2 (20 mg) | 4 | Not reported | Not reported | Not reported | Not reported |
| PART 1 Dose 3 (70 mg) | 21 | Not reported | Not reported | Not reported | Not reported |
| PART 1 Dose 4 (200 mg) | 17 | Not reported | Not reported | Not reported | Not reported |
| PART 1 Dose 5 (350 mg) | 22 | Not reported | Not reported | Not reported | Not reported |
| PART 1 Dose 6 (700 mg) | 11 | Not reported | Not reported | Not reported | Not reported |
| PART 1 Dose 7 (1400 mg) | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 17
- group Id
- OG004
- value
- 22
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 23
- group Id
- OG005
- value
- 12
- group Id
- OG006
- value
- 4
- units
- Participants
- description
- Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
- groups
- description
- INCAGN01949 7mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG000
- title
- PART 1 Dose 1 (7 mg)
- description
- INCAGN01949 20mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG001
- title
- PART 1 Dose 2 (20 mg)
- description
- INCAGN01949 70mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG002
- title
- PART 1 Dose 3 (70 mg)
- description
- INCAGN01949 200mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG003
- title
- PART 1 Dose 4 (200 mg)
- description
- INCAGN01949 350mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG004
- title
- PART 1 Dose 5 (350 mg)
- description
- INCAGN01949 700mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG005
- title
- PART 1 Dose 6 (700 mg)
- description
- INCAGN01949 1400mg administered intravenously over a 30-minute period on Day 1 of each cycle in subjects with advanced or metastatic solid tumors
- id
- OG006
- title
- PART 1 Dose 7 (1400 mg)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Full Analysis Set population include all subjects enrolled in the study who received at least 1 dose of INCAGN01949.
- reporting Status
- POSTED
- time Frame
- From screening through 60 days after end of treatment, up to 11 months
- title
- Number of Participants With Treatment-related Adverse Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice