TriangleNCT03126110 · OUTCOME
Phase 2: : Number of Participants With Any 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 approximately 27.4 months
What was measured
An 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 drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
Analysis population: Phase 2 FAS
Groups in this outcome
Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
| Group | Source count |
|---|---|
| Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | 8 |
| Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | 16 |
| Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | 46 |
| Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | 18 |
| Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | 4 |
| Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg | 8. | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg | 16 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg | 45 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg | 18 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8.
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 45
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 46
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- units
- Participants
- description
- An 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 drug(s). A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study medication.
- groups
- description
- Participants with programmed cell death protein/programmed cell death ligand 1 (PD-1/PD-L1) relapsed melanoma (RM) received INCAGN01876 300 mg administered IV Q2W in combination with ipilimumab 1 mg/kg administered IV Q6W.
- id
- OG000
- title
- Phase 2 Group C2 PD-1/PD-L1 RM: INCAGN01876 300 mg + Ipilimumab 1 mg/kg
- description
- Participants with gastric cancer (GC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG001
- title
- Phase 2 Group F GC: INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with squamous cell carcinoma of the head and neck (SCCHN) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG002
- title
- Phase 2 Group F SCCHN INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with cervical cancer (CC) received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG003
- title
- Phase 2 Group F CC: INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with PD-1/PD-L1 relapsed melanoma received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG004
- title
- Phase 2 Group F PD-1/PD-L1 RM: INCAGN01876 300 mg + Nivolumab 240 mg
- description
- Participants with gastric cancer, squamous cell carcinoma of the head and neck, cervical cancer, or PD-1/PD-L1 relapsed melanoma who had tumor lesions that were amenable to percutaneous biopsy received INCAGN01876 300 mg administered IV Q2W in combination with nivolumab 240 mg administered IV Q2W.
- id
- OG005
- title
- Phase 2 Group F Biopsy: INCAGN01876 300 mg + Nivolumab 240 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Phase 2 FAS
- reporting Status
- POSTED
- time Frame
- up to approximately 27.4 months
- title
- Phase 2: : Number of Participants With Any TEAE
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice