Trial Outcomes & Findings for A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723) (NCT NCT03085914)
NCT ID: NCT03085914
Last Updated: 2022-09-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Up to 21 months
Results posted on
2022-09-23
Participant Flow
The study was conducted at 9 study sites in the US. Phases 1 and 2 each consisted of Treatment Groups A-G, and every patient in the same group in Phases 1 and 2 received the same dose of epacadostat (100 mg BID oral), pembrolizumab (200 mg IV), and the respective chemotherapy regimens. Data analysis and summarization were performed by treatment group, by combining data of the same group in Phases 1 and 2.
A total of 70 participants were enrolled in the study. Study enrollment was permanently discontinued on 25 Oct 2018 as a strategic decision. At the time of data cut-off date of 25 Jan 2019, 11 participants were ongoing on treatment. . Phase 2 consisted of efficacy expansion and Mandatory biopsy cohorts. Phase 2 Efficacy expansion cohorts did not open for enrollment. Phase 2/Mandatory biopsy cohorts opened for enrollment and only groups C, D and E enrolled participants prior to study termination
Participant milestones
| Measure |
Group A: Epa + Pembrolizumab +mFOLFOX6
Epacadostat (Epa, 100 mg ) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg)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 (100mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) 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 (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
11
|
9
|
13
|
8
|
11
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
11
|
9
|
13
|
8
|
11
|
Reasons for withdrawal
| Measure |
Group A: Epa + Pembrolizumab +mFOLFOX6
Epacadostat (Epa, 100 mg ) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg)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 (100mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) 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 (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
6
|
6
|
4
|
1
|
5
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
2
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Reason was not specified,
|
2
|
2
|
2
|
3
|
3
|
3
|
6
|
|
Overall Study
Progressive Disease
|
0
|
0
|
2
|
2
|
1
|
1
|
1
|
|
Overall Study
Study Terminated by the Sponsor
|
0
|
0
|
0
|
1
|
2
|
1
|
0
|
Baseline Characteristics
A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)
Baseline characteristics by cohort
| Measure |
Group A: Epa + Pembrolizumab + mFOLFOX6
n=9 Participants
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
n=9 Participants
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
n=11 Participants
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
n=9 Participants
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
n=13 Participants
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
n=8 Participants
Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) 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
n=11 Participants
Epa (100 mg) oral BID continuousdaily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 8.03 • n=99 Participants
|
46.0 years
STANDARD_DEVIATION 14.98 • n=107 Participants
|
63.7 years
STANDARD_DEVIATION 12.11 • n=206 Participants
|
58.2 years
STANDARD_DEVIATION 12.96 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 10.21 • n=31 Participants
|
60.3 years
STANDARD_DEVIATION 12.01 • n=30 Participants
|
59.4 years
STANDARD_DEVIATION 12.24 • n=3 Participants
|
58.3 years
STANDARD_DEVIATION 12.54 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
36 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
34 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · White/Caucasian
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
55 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African-American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian/Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
67 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 21 monthsPopulation: The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
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.
Outcome measures
| Measure |
Group A: Epa + Pembrolizumab + mFOLFOX6
n=9 Participants
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
n=9 Participants
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
n=11 Participants
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
n=9 Participants
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
n=13 Participants
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
n=8 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
TEAE
|
9 Participants
|
9 Participants
|
11 Participants
|
9 Participants
|
13 Participants
|
8 Participants
|
11 Participants
|
|
Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAE
|
5 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
A DLT was defined as the occurrence of any of the protocol-specified toxicities occurring up to and including Day 28 for the cohorts where mFOLFOX6 and nab-paclitaxel/gemcitabine are administered and Day 21 for all other chemotherapy regimens in Phase 1, except those with a clear alternative explanation (eg, disease progression) or transient (≤ 72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination.
Outcome measures
| Measure |
Group A: Epa + Pembrolizumab + mFOLFOX6
n=9 Participants
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
n=9 Participants
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
n=11 Participants
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
n=9 Participants
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
n=13 Participants
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
n=8 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Phases 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 18Population: The full analysis set included all participants enrolled in the study who received at least 1 dose of epacadostat and have at least 1 postbaseline assessment or who discontinued epacadostat.
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Outcome measures
| Measure |
Group A: Epa + Pembrolizumab + mFOLFOX6
n=9 Participants
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
n=9 Participants
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
n=11 Participants
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
n=9 Participants
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
n=13 Participants
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
n=8 Participants
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
n=11 Participants
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.
|
|---|---|---|---|---|---|---|---|
|
Phases 1 and 2: Objective Response Rate (ORR)
Complete Response
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phases 1 and 2: Objective Response Rate (ORR)
Partial Response
|
5 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
Adverse Events
Group A: Epa + Pembrolizumab + mFOLFOX6
Serious events: 5 serious events
Other events: 9 other events
Deaths: 6 deaths
Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine
Serious events: 5 serious events
Other events: 8 other events
Deaths: 6 deaths
Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin
Serious events: 5 serious events
Other events: 11 other events
Deaths: 4 deaths
Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent
Serious events: 3 serious events
Other events: 9 other events
Deaths: 1 deaths
Group E: Epa + Pembrolizumab + Cyclophosphamide
Serious events: 6 serious events
Other events: 13 other events
Deaths: 6 deaths
Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent
Serious events: 4 serious events
Other events: 8 other events
Deaths: 2 deaths
Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
Serious events: 6 serious events
Other events: 10 other events
Deaths: 3 deaths
Total
Serious events: 34 serious events
Other events: 68 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Group A: Epa + Pembrolizumab + mFOLFOX6
n=9 participants at risk
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
n=9 participants at risk
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
n=11 participants at risk
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
n=9 participants at risk
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
n=13 participants at risk
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
n=8 participants at risk
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
n=11 participants at risk
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.
|
Total
n=70 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Ammonia increased
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix cancer metastatic
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Death
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Disease progression
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.9%
9/70 • Number of events 9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Large intestine infection
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Pure white cell aplasia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Seizure
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
Other adverse events
| Measure |
Group A: Epa + Pembrolizumab + mFOLFOX6
n=9 participants at risk
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
n=9 participants at risk
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
n=11 participants at risk
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
n=9 participants at risk
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
n=13 participants at risk
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
n=8 participants at risk
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
n=11 participants at risk
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.
|
Total
n=70 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Shift to the left
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
36.4%
4/11 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.6%
13/70 • Number of events 15 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Psychiatric disorders
Depression
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Diplopia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
10.0%
7/70 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
3/9 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
55.6%
5/9 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
54.5%
6/11 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
44.4%
4/9 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
30.8%
4/13 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
36.4%
4/11 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
37.1%
26/70 • Number of events 32 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 16 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 16 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Abdominal hernia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
25.0%
2/8 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.4%
8/70 • Number of events 9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Abnormal sensation in eye
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Ageusia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
25.0%
2/8 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.9%
16/70 • Number of events 17 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
45.5%
5/11 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.9%
9/70 • Number of events 9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Amylase increased
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
55.6%
5/9 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
36.4%
4/11 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
46.2%
6/13 • Number of events 9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
50.0%
4/8 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
38.6%
27/70 • Number of events 33 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Anorectal swelling
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
10.0%
7/70 • Number of events 8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
20.0%
14/70 • Number of events 16 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Asthenia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
10.0%
7/70 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Axillary pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
8.6%
6/70 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Bacteroides bacteraemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Blindness transient
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Blister
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Blood alkaline phosphatase increased
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
25.0%
2/8 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.6%
13/70 • Number of events 13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
8.6%
6/70 • Number of events 8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Blood pressure increased
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Body tinea
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
36.4%
4/11 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
14.3%
10/70 • Number of events 11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
10.0%
7/70 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Candida infection
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Cataract
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Catheter site pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Chest discomfort
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Chest wall mass
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Chills
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
36.4%
4/11 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
23.1%
3/13 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.9%
9/70 • Number of events 10 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Clostridium bacteraemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Conjunctivitis
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
25.0%
2/8 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.6%
13/70 • Number of events 15 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Injury, poisoning and procedural complications
Contusion
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
14.3%
10/70 • Number of events 11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
17.1%
12/70 • Number of events 13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Immune system disorders
Drug hypersensitivity
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Dry eye
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Dysaesthesia
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.4%
8/70 • Number of events 9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.1%
5/70 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
37.5%
3/8 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
10.0%
7/70 • Number of events 8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Ear infection
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Eczema eyelids
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
8.6%
6/70 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Eructation
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Eye inflammation
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Eye pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Facial pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Fatigue
|
77.8%
7/9 • Number of events 9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
55.6%
5/9 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
54.5%
6/11 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
77.8%
7/9 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
46.2%
6/13 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
50.0%
4/8 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
36.4%
4/11 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
55.7%
39/70 • Number of events 44 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Vascular disorders
Flushing
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.1%
5/70 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Gait disturbance
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.1%
5/70 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Generalised oedema
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Head titubation
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
36.4%
4/11 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
25.0%
2/8 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.9%
9/70 • Number of events 9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Hemiparesis
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Hordeolum
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Vascular disorders
Hot flush
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Vascular disorders
Hypertension
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Hypoaesthesia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Hypoaesthesia teeth
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
14.3%
10/70 • Number of events 13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
10.0%
7/70 • Number of events 12 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Influenza like illness
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
25.0%
2/8 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
14.3%
10/70 • Number of events 10 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
25.0%
2/8 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.4%
8/70 • Number of events 8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
50.0%
4/8 • Number of events 8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.6%
13/70 • Number of events 20 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Lipase increased
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
10.0%
7/70 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.1%
5/70 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
30.8%
4/13 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
25.0%
2/8 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.7%
11/70 • Number of events 12 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Migraine
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
10.0%
7/70 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
55.6%
5/9 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
72.7%
8/11 • Number of events 13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
77.8%
7/9 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
30.8%
4/13 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
50.0%
4/8 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
63.6%
7/11 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
52.9%
37/70 • Number of events 44 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Neuropathy peripheral
|
77.8%
7/9 • Number of events 8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
45.5%
5/11 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.1%
19/70 • Number of events 21 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.2%
2/9 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
55.6%
5/9 • Number of events 13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
45.5%
5/11 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
62.5%
5/8 • Number of events 9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
34.3%
24/70 • Number of events 44 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.4%
8/70 • Number of events 13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Neutrophil toxic granulation present
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Oedema
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.1%
5/70 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
5.7%
4/70 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Cardiac disorders
Palpitations
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
45.5%
5/11 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.4%
8/70 • Number of events 8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Photophobia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.1%
5/70 • Number of events 9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Renal and urinary disorders
Pollakiuria
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.1%
5/70 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
25.0%
2/8 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
14.3%
10/70 • Number of events 11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Pyrexia
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
8.6%
6/70 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Pyuria
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
44.4%
4/9 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
25.0%
2/8 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
20.0%
14/70 • Number of events 17 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Renal and urinary disorders
Renal salt-wasting syndrome
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Product Issues
Stent malfunction
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Endocrine disorders
Steroid withdrawal syndrome
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Injury, poisoning and procedural complications
Stoma site inflammation
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Injury, poisoning and procedural complications
Stoma site irritation
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
2.9%
2/70 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
45.5%
5/11 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.9%
16/70 • Number of events 20 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
General disorders
Temperature intolerance
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
77.8%
7/9 • Number of events 16 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
50.0%
4/8 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
21.4%
15/70 • Number of events 26 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Tinea cruris
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Transaminases increased
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour inflammation
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
17.1%
12/70 • Number of events 13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
25.0%
2/8 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.1%
5/70 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
18.2%
2/11 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
8.6%
6/70 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Reproductive system and breast disorders
Vaginal ulceration
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Vascular disorders
Vascular pain
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Eye disorders
Vision blurred
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
45.5%
5/11 • Number of events 5 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
33.3%
3/9 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
23.1%
3/13 • Number of events 4 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
37.5%
3/8 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
28.6%
20/70 • Number of events 21 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Weight decreased
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
15.4%
2/13 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
8.6%
6/70 • Number of events 6 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
Weight increased
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
9.1%
1/11 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/8 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
1.4%
1/70 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/13 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
4.3%
3/70 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
|
Investigations
White blood cell count decreased
|
11.1%
1/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
11.1%
1/9 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
27.3%
3/11 • Number of events 7 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
22.2%
2/9 • Number of events 2 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
7.7%
1/13 • Number of events 3 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.5%
1/8 • Number of events 1 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
0.00%
0/11 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
12.9%
9/70 • Number of events 16 • Up to 21 months
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, pembrolizumab, or an applicable chemotherapy regimen.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER