TriangleNCT03085914 · OUTCOME
Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
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 21 months
What was measured
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of epacadostat, pembrolizumab, or chemotherapy. Serious adverse event is defined as an event that meets 1 of the following criteria: is fatal or life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, incapacity, or a substantial disruption of a person's ability to conduct normal life functions, constitutes a congenital anomaly or birth defect,is a medically important event that may jeopardize the participant or may require medical or surgical intervention to prevent 1 of the outcomes listed above.
Analysis population: The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
Groups in this outcome
Group A: Epa + Pembrolizumab + mFOLFOX6
Epacadostat (Epa) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.
Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine
Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.
Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin
Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.
Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent
Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
Group E: Epa + Pembrolizumab + Cyclophosphamide
Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.
Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent
Epa oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
Epa oral BID continuousdaily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
| Group | Source count |
|---|---|
| Group A: Epa + Pembrolizumab + mFOLFOX6 | 9 |
| Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine | 9 |
| Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin | 11 |
| Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent | 9 |
| Group E: Epa + Pembrolizumab + Cyclophosphamide | 13 |
| Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent | 8 |
| Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent | 11 |
Reported measurements
TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A: Epa + Pembrolizumab + mFOLFOX6 | 9 | Not reported | Not reported | Not reported | Not reported |
| Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine | 9 | Not reported | Not reported | Not reported | Not reported |
| Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin | 11 | Not reported | Not reported | Not reported | Not reported |
| Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent | 9 | Not reported | Not reported | Not reported | Not reported |
| Group E: Epa + Pembrolizumab + Cyclophosphamide | 13 | Not reported | Not reported | Not reported | Not reported |
| Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent | 8 | Not reported | Not reported | Not reported | Not reported |
| Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent | 11 | Not reported | Not reported | Not reported | Not reported |
Serious TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group A: Epa + Pembrolizumab + mFOLFOX6 | 5 | Not reported | Not reported | Not reported | Not reported |
| Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine | 5 | Not reported | Not reported | Not reported | Not reported |
| Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin | 3 | Not reported | Not reported | Not reported | Not reported |
| Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent | 6 | Not reported | Not reported | Not reported | Not reported |
| Group E: Epa + Pembrolizumab + Cyclophosphamide | 4 | Not reported | Not reported | Not reported | Not reported |
| Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent | 6 | Not reported | Not reported | Not reported | Not reported |
| Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 11
- title
- TEAE
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 5
- title
- Serious TEAE
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 11
- units
- Participants
- description
- A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of epacadostat, pembrolizumab, or chemotherapy. Serious adverse event is defined as an event that meets 1 of the following criteria: is fatal or life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, incapacity, or a substantial disruption of a person's ability to conduct normal life functions, constitutes a congenital anomaly or birth defect,is a medically important event that may jeopardize the participant or may require medical or surgical intervention to prevent 1 of the outcomes listed above.
- groups
- description
- Epacadostat (Epa) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.
- id
- OG000
- title
- Group A: Epa + Pembrolizumab + mFOLFOX6
- description
- Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.
- id
- OG001
- title
- Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine
- description
- Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.
- id
- OG002
- title
- Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin
- description
- Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
- id
- OG003
- title
- Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent
- description
- Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.
- id
- OG004
- title
- Group E: Epa + Pembrolizumab + Cyclophosphamide
- description
- Epa oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
- id
- OG005
- title
- Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent
- description
- Epa oral BID continuousdaily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
- id
- OG006
- title
- Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
- reporting Status
- POSTED
- time Frame
- Up to 21 months
- title
- Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice