TriangleNCT02327078 · OUTCOME
Phase 2: Safety and Tolerability Measured by the Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Fatal Treatment Emergent AEs
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 35 months
What was measured
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug. Adverse events of grade 5 which result in death are called as fatal AEs.
Analysis population: The Phase 2 Safety population includes all participants enrolled in the study who received at least 1 dose of study drug.
Groups in this outcome
Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q4W on Days 1 and Day 29 of each 8-week cycle.
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg
Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
| Group | Source count |
|---|---|
| Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg | 83 |
| Phase 2: Epacadostat 300 mg + Nivolumab 240 mg | 176 |
Reported measurements
Participants with Treatment Emergent Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg | 82 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Epacadostat 300 mg + Nivolumab 240 mg | 176 | Not reported | Not reported | Not reported | Not reported |
Participants with Serious Treatment Emergent AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg | 40 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Epacadostat 300 mg + Nivolumab 240 mg | 89 | Not reported | Not reported | Not reported | Not reported |
Participants with Fatal Treatment Emergent AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Epacadostat 300 mg + Nivolumab 240 mg | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 176
- title
- Participants with Treatment Emergent Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 89
- title
- Participants with Serious Treatment Emergent AEs
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- title
- Participants with Fatal Treatment Emergent AEs
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 176
- units
- Participants
- description
- An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug. Adverse events of grade 5 which result in death are called as fatal AEs.
- groups
- description
- Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q4W on Days 1 and Day 29 of each 8-week cycle.
- id
- OG000
- title
- Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg
- description
- Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG001
- title
- Phase 2: Epacadostat 300 mg + Nivolumab 240 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Phase 2 Safety population includes all participants enrolled in the study who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- up to approximately 35 months
- title
- Phase 2: Safety and Tolerability Measured by the Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Fatal Treatment Emergent AEs
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice