Trial Outcomes & Findings for Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers (NCT NCT02178722)
NCT ID: NCT02178722
Last Updated: 2022-02-14
Results Overview
An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
444 participants
Primary outcome timeframe
Approximately 54 months
Results posted on
2022-02-14
Participant Flow
Participants took part in the study at 22 investigative sites in the United States from 17July 2014 to 06 November 2020.
Prior to 17May18 study amended/discontinued, 444 participants were enrolled. Survival follow up and monotherapy option after discontinuation of combination were removed so anyone in survival follow up were discontinued the study and were assigned to "study terminated by sponsor" because completed was not an option in the database for those in survival follow up. 1 patient on combo treatment did not move to the monotherapy so they were also assigned to this reason for discontinuing.
Participant milestones
| Measure |
Phase 1: Epacadostat 25 mg BID
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 mg BID
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 mg BID
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 300 mg BID
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 2: Epacadostat 100 mg BID
Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
20
|
18
|
20
|
382
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
20
|
18
|
20
|
382
|
Reasons for withdrawal
| Measure |
Phase 1: Epacadostat 25 mg BID
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 mg BID
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 mg BID
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 300 mg BID
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 2: Epacadostat 100 mg BID
Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
|
|---|---|---|---|---|---|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
33
|
|
Overall Study
Death
|
2
|
13
|
12
|
12
|
205
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
11
|
|
Overall Study
Study terminated by Sponsor
|
2
|
7
|
6
|
4
|
128
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers
Baseline characteristics by cohort
| Measure |
Phase 1: Epacadostat 25 mg BID
n=4 Participants
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 mg BID
n=20 Participants
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 mg BID
n=18 Participants
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 300 mg BID
n=20 Participants
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 2: Epacadostat 100 mg BID
n=382 Participants
Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
|
Total
n=444 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 18.01 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 12.97 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 13.67 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 13.06 • n=4 Participants
|
62.7 years
STANDARD_DEVIATION 11.60 • n=21 Participants
|
62.3 years
STANDARD_DEVIATION 11.92 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
208 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
201 Participants
n=21 Participants
|
236 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
1 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
337 Participants
n=21 Participants
|
393 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
353 Participants
n=21 Participants
|
413 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Approximately 54 monthsPopulation: The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.
Outcome measures
| Measure |
Phase 1: Epacadostat 25 mg BID
n=4 Participants
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 mg BID
n=20 Participants
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 mg BID
n=18 Participants
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 300 mg BID
n=20 Participants
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events
SAE
|
0 Percentage of Participants
|
40.0 Percentage of Participants
|
50.0 Percentage of Participants
|
45.0 Percentage of Participants
|
|
Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events
TEAS
|
100. Percentage of Participants
|
95.0 Percentage of Participants
|
94.4 Percentage of Participants
|
100. Percentage of Participants
|
PRIMARY outcome
Timeframe: Approximately 54 monthsPopulation: The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type.
ORR was percentage of participants with best overall response \[complete response (CR) or partial response (PR)\], per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Phase 1: Epacadostat 25 mg BID
n=382 Participants
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 mg BID
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 mg BID
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 300 mg BID
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR)
Triple negative breast cancer
|
11.1 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Microsatellite-instability high colorectal cancer
|
43.8 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Gastric cancer
|
22.2 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Hepatocellular carcinoma
|
16.7 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Melanoma - immune checkpoint-naïve
|
60.5 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Non-small cell lung cancer (NSCLC) (tumor proportion score (TPS) < 50% or indeterminate)
|
30.8 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
NSCLC programmed cell death ligand (PD-L1) low negative (TPS < 50%)
|
24.4 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Ovarian cancer
|
8.1 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Renal cell carcinoma
|
32.4 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Squamous cell carcinoma of the head and neck
|
33.3 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Transitional carcinoma of the genitourinary (GU) tract
|
30.6 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Diffuse large B-cell lymphoma
|
19.2 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Primary Refractory Melanoma
|
0.0 percentage of participants
|
—
|
—
|
—
|
|
Phase 2: Objective Response Rate (ORR)
Relapsed Melanoma
|
0.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 54 monthsPopulation: The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type and those who responded.
Duration of response is the time from the first overall response contributing to an objective response (complete or partial response) for DLBCL to the date of death or the date of first overall response of progressive diseasemeasured (by irRECIST for solid tumors or the Lugano Classification, whichever is earliest.
Outcome measures
| Measure |
Phase 1: Epacadostat 25 mg BID
n=105 Participants
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 mg BID
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 mg BID
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 300 mg BID
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR)
Hepatocellular Carcinoma
|
NA Months
Interval 2.04 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
Triple Negative Breast Cancer
|
NA Months
Interval 0.92 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
Immune Checkpoint-naïve Melanoma
|
NA Months
Interval 26.35 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
NSCLC high positive (PD-L1 TPS ≥ 50%)
|
12.44 Months
Interval 2.1 to 16.53
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
NSCLC low/negative or indeterminate (PD-L1 TPS < 50% or indeterminate)
|
11.93 Months
Interval 8.9 to 14.95
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
NSCLC (TPS 0%)
|
NA Months
Interval 7.43 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
NSCLC Unknown
|
10.84 Months
Interval 4.14 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
Renal Cell Carcinoma
|
16.95 Months
Interval 12.58 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
Squamous Cell Carcinoma of the Head and Neck
|
11.33 Months
Interval 3.94 to 31.74
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
Transitional Cell Carcinoma of the GU Tract
|
NA Months
Interval 10.64 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
Ovarian Cancer
|
NA Months
Interval 5.75 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
Gastric Cancer
|
NA Months
Interval 0.46 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
MSI high Colorectal Cancer
|
NA Months
Interval 4.17 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Response (DOR)
DLBCL
|
3.66 Months
Interval 0.72 to
insufficient number of participants with events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 54 monthsPopulation: The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type.
Progression-free survival is defined as number of days from the first day of taking study drug to the earlier of death or disease progression by irRECIST v1.1 for select solid tumors and modified Lugano Classification for DLBCL.
Outcome measures
| Measure |
Phase 1: Epacadostat 25 mg BID
n=382 Participants
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 mg BID
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 mg BID
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 300 mg BID
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Phase 2: Progression Free Survival (PFS)
Hepatocellular Carcinoma
|
5.49 Months
Interval 2.69 to 10.28
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
Triple Negative Breast Cancer
|
1.97 Months
Interval 1.87 to 2.92
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
Immune Checkpoint-naïve Melanoma
|
16.69 Months
Interval 6.24 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
Primary Refractory Melanoma
|
1.69 Months
Interval 1.25 to 2.14
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
Relapsed Melanoma
|
2.60 Months
Interval 2.14 to 4.21
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
NSCLC
|
4.09 Months
Interval 2.14 to 7.36
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
Renal Cell Carcinoma
|
4.50 Months
Interval 2.33 to 6.24
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
Squamous Cell Carcinoma of the Head and Neck
|
4.37 Months
Interval 2.3 to 7.79
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
Transitional Cell Carcinoma of the GU Tract
|
4.40 Months
Interval 2.14 to 8.9
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
Ovarian Cancer
|
2.10 Months
Interval 1.97 to 2.83
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
Gastric Cancer
|
1.97 Months
Interval 1.41 to 2.07
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
MSI high Colorectal Cancer
|
6.11 Months
Interval 2.07 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Progression Free Survival (PFS)
DLBCL
|
2.63 Months
Interval 1.87 to 4.01
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 54 monthsPopulation: The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type. The median time and the 90% CI were estimated using Kaplan-Meier method.
The duration of disease control is the time from the treatment start date to the first objective response of PD (by irRECIST v1.1 or Lugano Classification), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or better.
Outcome measures
| Measure |
Phase 1: Epacadostat 25 mg BID
n=191 Participants
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 mg BID
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 mg BID
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 300 mg BID
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Phase 2: Duration of Disease Control
Hepatocellular Carcinoma
|
10.38 Months
Interval 5.49 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Disease Control
Triple Negative Breast Cancer
|
11.47 Months
Interval 4.01 to 12.65
|
—
|
—
|
—
|
|
Phase 2: Duration of Disease Control
Immune Checkpoint-naïve Melanoma
|
30.29 Months
Interval 25.03 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Disease Control
Relapsed Melanoma
|
4.21 Months
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Disease Control
NSCLC Total
|
14.42 Months
Interval 8.51 to 19.45
|
—
|
—
|
—
|
|
Phase 2: Duration of Disease Control
Renal Cell Carcinoma
|
13.39 Months
Interval 5.13 to 18.86
|
—
|
—
|
—
|
|
Phase 2: Duration of Disease Control
Squamous Cell Carcinoma of the Head and Neck
|
9.18 Months
Interval 6.24 to 13.34
|
—
|
—
|
—
|
|
Phase 2: Duration of Disease Control
Transitional Cell Carcinoma of the GU Tract
|
15.36 Months
Interval 8.41 to 22.74
|
—
|
—
|
—
|
|
Phase 2: Duration of Disease Control
Ovarian Cancer
|
5.08 Months
Interval 3.29 to 7.79
|
—
|
—
|
—
|
|
Phase 2: Duration of Disease Control
Gastric Cancer
|
NA Months
Interval 2.56 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Disease Control
MSI high Colorectal Cancer
|
NA Months
Interval 6.11 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Duration of Disease Control
DLBCL
|
7.29 Months
Interval 4.01 to 10.91
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 54 monthsPopulation: The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug. Number analyzed indicated participants analyzed in the respective tumor type. The median time and the 90% CI were estimated using Kaplan-Meier method.
Overall survival is determined from the date of first dose until death due to any cause.
Outcome measures
| Measure |
Phase 1: Epacadostat 25 mg BID
n=382 Participants
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 mg BID
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 mg BID
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 300 mg BID
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Phase 2: Overall Survival (OS)
Hepatocellular Carcinoma
|
NA Months
Interval 8.94 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
Triple Negative Breast Cancer
|
5.16 Months
Interval 4.6 to 7.46
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
Immune Checkpoint-naïve Melanoma
|
NA Months
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
Primary Refractory Melanoma
|
NA Months
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
Relapsed Melanoma
|
NA Months
Interval 2.6 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
NSCLC
|
14.62 Months
Interval 9.72 to 24.38
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
Renal Cell Carcinoma
|
NA Months
Interval 18.4 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
Squamous Cell Carcinoma of the Head and Neck
|
8.34 Months
Interval 4.37 to 15.41
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
Transitional Cell Carcinoma of the GU Tract
|
13.44 Months
Interval 8.41 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
Ovarian Cancer
|
13.11 Months
Interval 8.34 to 25.92
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
Gastric Cancer
|
4.04 Months
Interval 1.97 to 15.84
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
MSI high Colorectal Cancer
|
NA Months
Interval 8.15 to
insufficient number of participants with events
|
—
|
—
|
—
|
|
Phase 2: Overall Survival (OS)
DLBCL
|
11.79 Months
Interval 4.37 to
insufficient number of participants with events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 54 monthsPopulation: The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type.
Ordinal categorical response score, determined by radiographic disease assessments per irRECIST v1.1. The 5-category ordinal response endpoint is determined at a given timepoint by classifying response into one of the following groups: 1 = Complete response per irRECIST v1.1 2 = Very good response, defined as \> 60% tumor reduction 3 = Minor response, defined as \> 30% to ≤ 60% tumor reduction 4 = Stable disease per irRECIST v1.1 5 = Progressive disease per irRECIST v1.1
Outcome measures
| Measure |
Phase 1: Epacadostat 25 mg BID
n=382 Participants
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 mg BID
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 mg BID
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 300 mg BID
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Phase 2: Ordinal Categorical Response Score
Hepatocellular Carcinoma · Complete Response - Score 1
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Hepatocellular Carcinoma · Very Good Response - Score 2
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Hepatocellular Carcinoma · Minor Response - Score 3
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Hepatocellular Carcinoma · Stable Disease - Score 4
|
11 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Hepatocellular Carcinoma · Progressive Disease - Score 5
|
8 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Hepatocellular Carcinoma · Unable to Evaluable
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Triple Negative Breast Cancer · Complete Response - Score 1
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Triple Negative Breast Cancer · Very Good Response - Score 2
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Triple Negative Breast Cancer · Minor Response - Score 3
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Triple Negative Breast Cancer · Stable Disease - Score 4
|
7 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Triple Negative Breast Cancer · Progressive Disease - Score 5
|
19 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Triple Negative Breast Cancer · Unable to Evaluable
|
6 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Immune Checkpoint-naïve Melanoma · Complete Response - Score 1
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Immune Checkpoint-naïve Melanoma · Very Good Response - Score 2
|
17 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Immune Checkpoint-naïve Melanoma · Minor Response - Score 3
|
6 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Immune Checkpoint-naïve Melanoma · Stable Disease - Score 4
|
5 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Immune Checkpoint-naïve Melanoma · Progressive Disease - Score 5
|
10 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Immune Checkpoint-naïve Melanoma · Unable to Evaluable
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Primary Refractory Melanoma · Complete Response - Score 1
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Primary Refractory Melanoma · Very Good Response - Score 2
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Primary Refractory Melanoma · Minor Response - Score 3
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Primary Refractory Melanoma · Stable Disease - Score 4
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Primary Refractory Melanoma · Progressive Disease - Score 5
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Primary Refractory Melanoma · Unable to Evaluable
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Relapsed Melanoma · Complete Response - Score 1
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Relapsed Melanoma · Very Good Response - Score 2
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Relapsed Melanoma · Minor Response - Score 3
|
5 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Relapsed Melanoma · Stable Disease - Score 4
|
8 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Relapsed Melanoma · Progressive Disease - Score 5
|
10 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Relapsed Melanoma · Unable to Evaluable
|
6 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
NSCLC · Complete Response - Score 1
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
NSCLC · Very Good Response - Score 2
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
NSCLC · Minor Response - Score 3
|
8 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
NSCLC · Stable Disease - Score 4
|
15 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
NSCLC · Progressive Disease - Score 5
|
24 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
NSCLC · Unable to Evaluable
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Renal Cell Carcinoma · Complete Response - Score 1
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Renal Cell Carcinoma · Very Good Response - Score 2
|
6 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Renal Cell Carcinoma · Minor Response - Score 3
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Renal Cell Carcinoma · Stable Disease - Score 4
|
10 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Renal Cell Carcinoma · Progressive Disease - Score 5
|
13 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Renal Cell Carcinoma · Unable to Evaluable
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Squamous Cell Carcinoma of the Head and Neck · Complete Response - Score 1
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Squamous Cell Carcinoma of the Head and Neck · Very Good Response - Score 2
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Squamous Cell Carcinoma of the Head and Neck · Minor Response - Score 3
|
5 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Squamous Cell Carcinoma of the Head and Neck · Stable Disease - Score 4
|
8 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Squamous Cell Carcinoma of the Head and Neck · Progressive Disease - Score 5
|
10 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Squamous Cell Carcinoma of the Head and Neck · Unable to Evaluable
|
6 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Transitional Cell Carcinoma of the GU Tract · Complete Response - Score 1
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Transitional Cell Carcinoma of the GU Tract · Very Good Response - Score 2
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Transitional Cell Carcinoma of the GU Tract · Minor Response - Score 3
|
5 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Transitional Cell Carcinoma of the GU Tract · Stable Disease - Score 4
|
10 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Transitional Cell Carcinoma of the GU Tract · Progressive Disease - Score 5
|
11 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Transitional Cell Carcinoma of the GU Tract · Unable to Evaluable
|
4 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Ovarian Cancer · Complete Response - Score 1
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Ovarian Cancer · Very Good Response - Score 2
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Ovarian Cancer · Minor Response - Score 3
|
2 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Ovarian Cancer · Stable Disease - Score 4
|
11 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Ovarian Cancer · Progressive Disease - Score 5
|
16 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Ovarian Cancer · Unable to Evaluable
|
7 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Gastric Cancer · Complete Response - Score 1
|
0 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Gastric Cancer · Very Good Response - Score 2
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Gastric Cancer · Minor Response - Score 3
|
5 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Gastric Cancer · Stable Disease - Score 4
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Gastric Cancer · Progressive Disease - Score 5
|
11 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
Gastric Cancer · Unable to Evaluable
|
9 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
MSI high Colorectal Cancer · Complete Response - Score 1
|
1 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
MSI high Colorectal Cancer · Very Good Response - Score 2
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
MSI high Colorectal Cancer · Minor Response - Score 3
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
MSI high Colorectal Cancer · Stable Disease - Score 4
|
3 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
MSI high Colorectal Cancer · Progressive Disease - Score 5
|
5 Participants
|
—
|
—
|
—
|
|
Phase 2: Ordinal Categorical Response Score
MSI high Colorectal Cancer · Unable to Evaluable
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 54 monthsPopulation: The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Treatment groups for this population were determined according to the actual treatment the participant receives on Day 1. All safety analyses were conducted using the safety evaluable population.
Outcome measures
| Measure |
Phase 1: Epacadostat 25 mg BID
n=382 Participants
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 mg BID
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 mg BID
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 300 mg BID
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
|---|---|---|---|---|
|
Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events
Treatment-Emergent Adverse Events (TEAE)
|
100 Percentage of Participants
|
—
|
—
|
—
|
|
Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events
Serious Treatment-Emergent Adverse Events
|
51.0 Percentage of Participants
|
—
|
—
|
—
|
Adverse Events
Phase 1: Epacadostat 25 mg BID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1: Epacadostat 50 MG BID
Serious events: 8 serious events
Other events: 18 other events
Deaths: 13 deaths
Phase 1: Epacadostat 100 MG BID
Serious events: 9 serious events
Other events: 17 other events
Deaths: 12 deaths
Phase 1: Epacadostat 300 MG BID
Serious events: 9 serious events
Other events: 20 other events
Deaths: 14 deaths
Phase 2: Epacadostat 100 MG BID
Serious events: 195 serious events
Other events: 375 other events
Deaths: 209 deaths
Total
Serious events: 221 serious events
Other events: 434 other events
Deaths: 250 deaths
Serious adverse events
| Measure |
Phase 1: Epacadostat 25 mg BID
n=4 participants at risk
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 MG BID
n=20 participants at risk
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 MG BID
n=18 participants at risk
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1
|
Phase 1: Epacadostat 300 MG BID
n=20 participants at risk
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1
|
Phase 2: Epacadostat 100 MG BID
n=382 participants at risk
Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
|
Total
n=444 participants at risk
Total
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.1%
12/382 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.2%
14/444 • Number of events 15 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
7/382 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Asthenia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Chest pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Cranial nerve disorder
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Death
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Product Issues
Device occlusion
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Disease progression
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.4%
9/382 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.3%
10/444 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.4%
9/382 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.5%
11/444 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Facial pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Fatigue
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Gastrointestinal wall thickening
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Eye disorders
Macular degeneration
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
8.6%
33/382 • Number of events 33 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.9%
35/444 • Number of events 35 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic lymphoma
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.1%
12/382 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
13/444 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage I
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Oedema
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Physical deconditioning
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
11/382 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.7%
12/444 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.9%
15/382 • Number of events 16 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.6%
16/444 • Number of events 17 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
7/382 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Renal abscess
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.1%
8/382 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.3%
10/444 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
11/382 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.5%
11/444 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Spinal cord haemorrhage
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.4%
9/382 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.3%
10/444 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
Other adverse events
| Measure |
Phase 1: Epacadostat 25 mg BID
n=4 participants at risk
Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 50 MG BID
n=20 participants at risk
Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
|
Phase 1: Epacadostat 100 MG BID
n=18 participants at risk
Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1
|
Phase 1: Epacadostat 300 MG BID
n=20 participants at risk
Epacadostat 300 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1
|
Phase 2: Epacadostat 100 MG BID
n=382 participants at risk
Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
|
Total
n=444 participants at risk
Total
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
8/444 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.1%
8/382 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.3%
10/444 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal paraesthesia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.1%
8/382 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.3%
10/444 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
11/382 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.7%
12/444 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.4%
13/382 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.2%
14/444 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.7%
14/382 • Number of events 16 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.4%
15/444 • Number of events 17 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
11/382 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.7%
12/444 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
19/382 • Number of events 19 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
25/444 • Number of events 25 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
13.9%
53/382 • Number of events 60 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
13.3%
59/444 • Number of events 68 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.0%
23/382 • Number of events 25 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
25/444 • Number of events 27 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.7%
3/18 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
9.4%
36/382 • Number of events 46 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
9.5%
42/444 • Number of events 54 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.0%
9/444 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Amnesia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Amylase increased
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
9.2%
35/382 • Number of events 45 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
8.8%
39/444 • Number of events 54 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
12.6%
48/382 • Number of events 65 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
12.4%
55/444 • Number of events 78 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.0%
23/382 • Number of events 24 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.0%
31/444 • Number of events 33 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
4/4 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
45.0%
9/20 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
22.2%
4/18 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
30.0%
6/20 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.8%
64/382 • Number of events 88 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
19.6%
87/444 • Number of events 121 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
22.2%
4/18 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.5%
44/382 • Number of events 56 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.5%
51/444 • Number of events 66 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Asthenia
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
20.0%
4/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.1%
27/382 • Number of events 28 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.9%
35/444 • Number of events 37 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
20.0%
4/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
38.9%
7/18 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
25.0%
5/20 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
12.6%
48/382 • Number of events 58 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
14.6%
65/444 • Number of events 78 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
8.1%
31/382 • Number of events 37 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
8.1%
36/444 • Number of events 42 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
7/382 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
8/444 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Blood calcium decreased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.5%
25/382 • Number of events 29 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.1%
27/444 • Number of events 32 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Blood iron decreased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Body temperature increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Body tinea
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Bronchitis
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.4%
9/382 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.5%
11/444 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
8/444 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Cerebral cyst
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Cheilitis
|
25.0%
1/4 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Chest discomfort
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
7/382 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.3%
10/444 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Chills
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
20.0%
4/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
9.4%
36/382 • Number of events 40 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.1%
45/444 • Number of events 50 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Chromaturia
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.1%
8/382 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.0%
9/444 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Constipation
|
75.0%
3/4 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
40.0%
8/20 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
22.2%
4/18 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
22.5%
86/382 • Number of events 94 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
23.4%
104/444 • Number of events 120 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
3/4 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
35.0%
7/20 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.7%
3/18 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
45.0%
9/20 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
26.2%
100/382 • Number of events 114 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
27.5%
122/444 • Number of events 139 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
20.0%
4/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
45.0%
9/20 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
24.9%
95/382 • Number of events 103 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
24.5%
109/444 • Number of events 117 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
8.4%
32/382 • Number of events 34 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.7%
34/444 • Number of events 36 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Psychiatric disorders
Depression
|
50.0%
2/4 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.7%
18/382 • Number of events 20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.4%
24/444 • Number of events 26 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
3/4 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
25.0%
5/20 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
38.9%
7/18 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
25.0%
5/20 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
25.9%
99/382 • Number of events 142 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
26.8%
119/444 • Number of events 179 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Disturbance in attention
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
25.0%
5/20 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.5%
40/382 • Number of events 49 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.3%
50/444 • Number of events 64 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
22.2%
4/18 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.3%
24/382 • Number of events 26 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.4%
33/444 • Number of events 35 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.2%
16/382 • Number of events 18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.5%
20/444 • Number of events 22 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.6%
10/382 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.7%
12/444 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
2/4 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
33.3%
6/18 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
25.0%
5/20 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
18.1%
69/382 • Number of events 77 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
18.9%
84/444 • Number of events 96 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.2%
20/382 • Number of events 23 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
22/444 • Number of events 25 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
8/444 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Ear and labyrinth disorders
Ear discomfort
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Early satiety
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.1%
12/382 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.4%
15/444 • Number of events 16 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.1%
8/382 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
13/444 • Number of events 18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Eye disorders
Eye pruritus
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Face oedema
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.0%
23/382 • Number of events 24 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.9%
26/444 • Number of events 27 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
65.0%
13/20 • Number of events 17 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
50.0%
9/18 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
65.0%
13/20 • Number of events 20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
48.4%
185/382 • Number of events 220 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
50.2%
223/444 • Number of events 272 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.5%
17/382 • Number of events 19 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.7%
21/444 • Number of events 23 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Flatulence
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.6%
10/382 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.7%
12/444 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Foreign body reaction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Fungal infection
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Gastroenteritis
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
1/4 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.4%
13/382 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.3%
19/444 • Number of events 21 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Glossodynia
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
7/382 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.0%
9/444 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
11/382 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
13/444 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
30.0%
6/20 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
20.0%
4/20 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.2%
58/382 • Number of events 77 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.0%
71/444 • Number of events 100 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
7/382 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.0%
9/444 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.7%
14/382 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.6%
16/444 • Number of events 16 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.0%
23/382 • Number of events 31 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.5%
29/444 • Number of events 42 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.6%
10/382 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.7%
12/444 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.7%
3/18 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.5%
21/382 • Number of events 26 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.9%
26/444 • Number of events 34 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.4%
9/382 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.5%
11/444 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.9%
15/382 • Number of events 17 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.6%
16/444 • Number of events 18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.1%
12/382 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.8%
17/444 • Number of events 19 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.7%
14/382 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.8%
17/444 • Number of events 17 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.4%
9/382 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.5%
11/444 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
8/444 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Endocrine disorders
Hypogonadism
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.9%
30/382 • Number of events 39 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.7%
34/444 • Number of events 43 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.1%
12/382 • Number of events 17 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.2%
14/444 • Number of events 19 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.7%
3/18 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.2%
39/382 • Number of events 57 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
9.7%
43/444 • Number of events 63 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.5%
17/382 • Number of events 25 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.3%
19/444 • Number of events 31 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
11/382 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.7%
12/444 • Number of events 15 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Endocrine disorders
Hypothalamo-pituitary disorder
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.6%
29/382 • Number of events 30 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.2%
32/444 • Number of events 33 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Influenza
|
25.0%
1/4 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.4%
9/382 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.5%
11/444 • Number of events 15 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.9%
15/382 • Number of events 15 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.8%
17/444 • Number of events 17 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Psychiatric disorders
Insomnia
|
50.0%
2/4 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
30.0%
6/20 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.5%
44/382 • Number of events 48 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
12.4%
55/444 • Number of events 59 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Jugular vein thrombosis
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Lipase decreased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.7%
3/18 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
12.6%
48/382 • Number of events 80 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
12.2%
54/444 • Number of events 99 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Malaise
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Mass
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Medical device pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
7/382 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
8/444 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
6/382 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
50.0%
2/4 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.0%
23/382 • Number of events 31 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
25/444 • Number of events 33 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.2%
16/382 • Number of events 16 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.3%
19/444 • Number of events 19 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.4%
13/382 • Number of events 16 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.4%
15/444 • Number of events 18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.3%
28/382 • Number of events 30 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
8.1%
36/444 • Number of events 39 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.3%
10/444 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
20.0%
4/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.7%
3/18 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
25.0%
5/20 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.8%
22/382 • Number of events 25 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.7%
34/444 • Number of events 39 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Nail bed disorder
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.2%
20/382 • Number of events 22 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
25/444 • Number of events 27 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
20.0%
4/20 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.3%
24/382 • Number of events 24 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.8%
30/444 • Number of events 38 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
45.0%
9/20 • Number of events 20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
27.8%
5/18 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
55.0%
11/20 • Number of events 18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
30.1%
115/382 • Number of events 143 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
32.2%
143/444 • Number of events 192 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.1%
12/382 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.2%
14/444 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.7%
14/382 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.6%
16/444 • Number of events 16 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
8.1%
31/382 • Number of events 32 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.7%
34/444 • Number of events 35 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Oedema
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.7%
3/18 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.5%
40/382 • Number of events 46 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.0%
49/444 • Number of events 58 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
19/382 • Number of events 21 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.4%
24/444 • Number of events 28 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.5%
17/382 • Number of events 19 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.7%
21/444 • Number of events 24 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
75.0%
3/4 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
25.0%
5/20 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.5%
40/382 • Number of events 45 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.5%
51/444 • Number of events 60 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.4%
9/382 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.5%
11/444 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.4%
9/382 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.3%
10/444 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.6%
10/382 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.7%
12/444 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.7%
14/382 • Number of events 16 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.8%
17/444 • Number of events 19 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
7/382 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.0%
9/444 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
6.5%
25/382 • Number of events 28 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.0%
31/444 • Number of events 36 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
75.0%
3/4 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
30.0%
6/20 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
45.0%
9/20 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
20.4%
78/382 • Number of events 96 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
22.1%
98/444 • Number of events 126 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.7%
3/18 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
45.0%
9/20 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.2%
58/382 • Number of events 74 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.4%
73/444 • Number of events 93 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
2/4 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
30.0%
6/20 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
30.0%
6/20 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
22.5%
86/382 • Number of events 108 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
22.7%
101/444 • Number of events 135 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
20.0%
4/20 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
19/382 • Number of events 23 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.9%
26/444 • Number of events 32 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
11/382 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.4%
15/444 • Number of events 24 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.1%
8/382 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.5%
11/444 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.8%
7/382 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.0%
9/444 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.6%
10/382 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
13/444 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.5%
21/382 • Number of events 25 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.2%
23/444 • Number of events 27 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.1%
8/382 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.7%
12/444 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Slow speech
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
2/4 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
11/382 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.4%
15/444 • Number of events 20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Swelling
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Swelling face
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.52%
2/382 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.68%
3/444 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
16.7%
3/18 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.9%
11/382 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.6%
16/444 • Number of events 19 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
Taste disorder
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.6%
10/382 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.7%
12/444 • Number of events 12 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
General disorders
Temperature intolerance
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.3%
5/382 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Troponin increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
15.0%
3/20 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
11.1%
2/18 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
8.1%
31/382 • Number of events 38 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
8.6%
38/444 • Number of events 48 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.6%
10/382 • Number of events 10 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.2%
14/444 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.4%
6/444 • Number of events 6 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.3%
28/382 • Number of events 36 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
7.2%
32/444 • Number of events 47 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.90%
4/444 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.7%
14/382 • Number of events 14 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
3.6%
16/444 • Number of events 16 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.0%
4/382 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.6%
7/444 • Number of events 7 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
10.0%
2/20 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.79%
3/382 • Number of events 3 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
1.1%
5/444 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
20.0%
4/20 • Number of events 5 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
22.2%
4/18 • Number of events 8 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
50.0%
10/20 • Number of events 13 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
20.4%
78/382 • Number of events 99 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
21.8%
97/444 • Number of events 127 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/382 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.23%
1/444 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
22.2%
4/18 • Number of events 4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
9.2%
35/382 • Number of events 37 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
9.0%
40/444 • Number of events 42 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Investigations
Weight increased
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.1%
8/382 • Number of events 9 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
2.3%
10/444 • Number of events 11 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.6%
1/18 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.2%
16/382 • Number of events 18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
4.3%
19/444 • Number of events 21 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
25.0%
1/4 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/4 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
5.0%
1/20 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/18 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.00%
0/20 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.26%
1/382 • Number of events 1 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
0.45%
2/444 • Number of events 2 • Approximately 54 months
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER