Trial Outcomes & Findings for Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05) (NCT NCT03322540)
NCT ID: NCT03322540
Last Updated: 2025-08-22
Results Overview
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on blinded independent central review (BICR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
Up to approximately 6 months
Results posted on
2025-08-22
Participant Flow
A total of 154 participants were randomized in 1:1 to either combination (Pembrolizumab+Epacadostat) and control (Pembrolizumab+Placebo) groups. As of Amendment 05, study design was changed to unblinded, open-label, and single-arm (epacadostat and placebo were removed).
Phase 3 design of the study has been amended soon after it had started to a prospectively randomized phase 2 study. At the time of amendment existing participants were given a choice to move/participate in the new phase 2 study, and some participants who chose to discontinue the study at phase 3 were assigned to "study terminated by sponsor" as the reason for not completing the study in disposition table. The results posted are combined in the prospectively redesigned phase 2 trial.
Participant milestones
| Measure |
Pembrolizumab + Epacadostat
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
|
Pembrolizumab + Placebo
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
77
|
|
Overall Study
Number of Subjects Received Treatment (Actual Treatment) (ASaT)
|
75
|
77
|
|
Overall Study
COMPLETED
|
46
|
40
|
|
Overall Study
NOT COMPLETED
|
31
|
37
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Epacadostat
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
|
Pembrolizumab + Placebo
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
|
|---|---|---|
|
Overall Study
Death
|
21
|
28
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
7
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Study terminated by sponsor
|
0
|
1
|
Baseline Characteristics
Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Epacadostat
n=77 Participants
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
|
Pembrolizumab + Placebo
n=77 Participants
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
65.3 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic Or Latino · Hispanic Or Latino
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic Or Latino · Not Hispanic Or Latino
|
66 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic Or Latino · Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic Or Latino · Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 6 monthsPopulation: ITT population consisted of all randomized participants.
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on blinded independent central review (BICR).
Outcome measures
| Measure |
Pembrolizumab + Epacadostat
n=77 Participants
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
|
Pembrolizumab + Placebo
n=77 Participants
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
|
|---|---|---|
|
Objective Response Rate (ORR) of Pembrolizumab Plus Epacadostat Versus Pembrolizumab Plus Placebo
|
32.5 percentage of participants
Interval 22.2 to 44.1
|
39.0 percentage of participants
Interval 28.0 to 50.8
|
SECONDARY outcome
Timeframe: Up to approximately 36 monthsPopulation: ITT population consisted of all randomized participants.
PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 based on BICR or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Pembrolizumab + Epacadostat
n=77 Participants
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
|
Pembrolizumab + Placebo
n=77 Participants
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
|
|---|---|---|
|
Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
|
6.7 months
Interval 4.3 to 8.2
|
6.2 months
Interval 4.3 to
Upper bound was not estimable
|
SECONDARY outcome
Timeframe: Up to approximately 36 monthsPopulation: ITT population consisted of all randomized participants.
OS is defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Pembrolizumab + Epacadostat
n=77 Participants
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
|
Pembrolizumab + Placebo
n=77 Participants
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
|
|---|---|---|
|
Overall Survival (OS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
|
NA Months
Median Overall Survival was not reached
|
NA Months
Median Overall Survival was not reached
|
SECONDARY outcome
Timeframe: Up to approximately 36 monthsPopulation: DOR included all responders in ITT population. Response duration was calculated from product-limit (Kaplan-Meier) method for censored data.
DOR is defined as the time from the earliest date of qualifying response until earliest date of disease progression per RECIST v1.1 or death from any cause, whichever comes first.
Outcome measures
| Measure |
Pembrolizumab + Epacadostat
n=77 Participants
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
|
Pembrolizumab + Placebo
n=77 Participants
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
|
|---|---|---|
|
Duration of Response (DOR) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
|
6.2 Months
Interval 1.9 to 6.5
|
NA Months
Interval 1.9 to 8.6
Median was not reached in this arm.
|
SECONDARY outcome
Timeframe: Up to 37 monthsAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Pembrolizumab + Epacadostat
n=75 Participants
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
|
Pembrolizumab + Placebo
n=77 Participants
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
72 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Up to 37 monthsAE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Pembrolizumab + Epacadostat
n=75 Participants
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
|
Pembrolizumab + Placebo
n=77 Participants
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to AEs
|
15 Participants
|
12 Participants
|
Adverse Events
Pembrolizumab + Epacadostat
Serious events: 36 serious events
Other events: 69 other events
Deaths: 23 deaths
Pembrolizumab + Placebo
Serious events: 35 serious events
Other events: 67 other events
Deaths: 29 deaths
Total
Serious events: 71 serious events
Other events: 136 other events
Deaths: 52 deaths
Serious adverse events
| Measure |
Pembrolizumab + Epacadostat
n=75 participants at risk
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
|
Pembrolizumab + Placebo
n=77 participants at risk
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
|
Total
n=152 participants at risk
Total
|
|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
2/75 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
2/152 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.7%
2/75 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
2/152 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Autoimmune myocarditis
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
1.3%
1/75 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Death
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Fear of death
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
General physical health deterioration
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
2/152 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
High-grade B-cell lymphoma
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
2.6%
2/77 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
2/152 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
2.6%
2/77 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
2/152 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
2/152 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
8.0%
6/75 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
10.4%
8/77 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.2%
14/152 • Number of events 14 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/75 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
2/152 • Number of events 3 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
8.0%
6/75 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.1%
7/77 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
8.6%
13/152 • Number of events 13 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
4/75 • Number of events 4 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
2.6%
2/77 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
3.9%
6/152 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Polyneuropathy
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Pseudodiverticular disease
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pyelonephritis
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
2/152 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Septic shock
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pseudoprogression
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/77 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/75 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
0.66%
1/152 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Pembrolizumab + Epacadostat
n=75 participants at risk
Participants received pembrolizumab 200 mg as an intravenous (IV) infusion, every three weeks (Q3W) starting on Day 1 of each cycle for up to 35 administrations in combination with epacadostat 100 mg orally, twice daily. Epacodostat administration was discontinued after the implementation of protocol amendment 05.
|
Pembrolizumab + Placebo
n=77 participants at risk
Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05.
|
Total
n=152 participants at risk
Total
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
6.7%
5/75 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
6.5%
5/77 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
6.6%
10/152 • Number of events 13 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Amylase increased
|
10.7%
8/75 • Number of events 9 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.2%
4/77 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.9%
12/152 • Number of events 17 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.3%
7/75 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
13.0%
10/77 • Number of events 12 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
11.2%
17/152 • Number of events 20 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.7%
17/75 • Number of events 22 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
13.0%
10/77 • Number of events 12 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
17.8%
27/152 • Number of events 34 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
4/75 • Number of events 4 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.2%
4/77 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.3%
8/152 • Number of events 11 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
10.7%
8/75 • Number of events 9 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.8%
6/77 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.2%
14/152 • Number of events 17 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
10/75 • Number of events 13 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
10.4%
8/77 • Number of events 11 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
11.8%
18/152 • Number of events 24 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
5.3%
4/75 • Number of events 4 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.1%
7/77 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.2%
11/152 • Number of events 12 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Chest pain
|
6.7%
5/75 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.8%
6/77 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.2%
11/152 • Number of events 12 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Chills
|
5.3%
4/75 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
3.3%
5/152 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
26.7%
20/75 • Number of events 23 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
23.4%
18/77 • Number of events 21 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
25.0%
38/152 • Number of events 44 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.3%
7/75 • Number of events 9 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
10.4%
8/77 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.9%
15/152 • Number of events 17 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.7%
17/75 • Number of events 18 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
13.0%
10/77 • Number of events 12 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
17.8%
27/152 • Number of events 30 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.3%
16/75 • Number of events 30 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
22.1%
17/77 • Number of events 25 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
21.7%
33/152 • Number of events 55 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
6.7%
5/75 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.8%
6/77 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.2%
11/152 • Number of events 11 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
5/75 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.2%
4/77 • Number of events 4 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.9%
9/152 • Number of events 9 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
5.3%
4/75 • Number of events 4 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
3.3%
5/152 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.3%
10/75 • Number of events 13 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
13.0%
10/77 • Number of events 13 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
13.2%
20/152 • Number of events 26 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
12.0%
9/75 • Number of events 11 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
20.8%
16/77 • Number of events 21 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
16.4%
25/152 • Number of events 32 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.0%
6/75 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.1%
7/77 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
8.6%
13/152 • Number of events 13 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
17.3%
13/75 • Number of events 15 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.2%
4/77 • Number of events 4 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
11.2%
17/152 • Number of events 19 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.0%
6/75 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
2.6%
2/77 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.3%
8/152 • Number of events 9 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.7%
2/75 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.1%
7/77 • Number of events 11 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.9%
9/152 • Number of events 16 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
10.7%
8/75 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.8%
6/77 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.2%
14/152 • Number of events 14 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
4/75 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
6.5%
5/77 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.9%
9/152 • Number of events 13 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.0%
6/75 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
4.6%
7/152 • Number of events 9 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
2.7%
2/75 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.2%
4/77 • Number of events 4 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
3.9%
6/152 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
13.3%
10/75 • Number of events 11 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.8%
6/77 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
10.5%
16/152 • Number of events 17 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
8.0%
6/75 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.2%
4/77 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
6.6%
10/152 • Number of events 12 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Lipase increased
|
12.0%
9/75 • Number of events 9 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.2%
4/77 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
8.6%
13/152 • Number of events 14 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Lymphocyte count decreased
|
1.3%
1/75 • Number of events 1 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.2%
4/77 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
3.3%
5/152 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
2/75 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.1%
7/77 • Number of events 9 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.9%
9/152 • Number of events 11 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
2.7%
2/75 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
10.4%
8/77 • Number of events 10 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
6.6%
10/152 • Number of events 12 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
18.7%
14/75 • Number of events 16 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
10.4%
8/77 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
14.5%
22/152 • Number of events 24 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
5.3%
4/75 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
6.5%
5/77 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.9%
9/152 • Number of events 11 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral candidiasis
|
2.7%
2/75 • Number of events 3 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.2%
4/77 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
3.9%
6/152 • Number of events 9 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
5/75 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.2%
4/77 • Number of events 4 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
5.9%
9/152 • Number of events 10 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
5.3%
4/75 • Number of events 4 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
3.9%
3/77 • Number of events 3 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
4.6%
7/152 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
4/75 • Number of events 4 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
2.6%
2/77 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
3.9%
6/152 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.3%
16/75 • Number of events 21 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
20.8%
16/77 • Number of events 22 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
21.1%
32/152 • Number of events 43 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
9.3%
7/75 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
10.4%
8/77 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.9%
15/152 • Number of events 16 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
15/75 • Number of events 22 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
14.3%
11/77 • Number of events 16 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
17.1%
26/152 • Number of events 38 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
4/75 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.1%
7/77 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.2%
11/152 • Number of events 13 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
5/75 • Number of events 5 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
1.3%
1/77 • Number of events 2 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
3.9%
6/152 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
6/75 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
10.4%
8/77 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.2%
14/152 • Number of events 14 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
4/75 • Number of events 4 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.8%
6/77 • Number of events 10 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
6.6%
10/152 • Number of events 14 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
7/75 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
7.8%
6/77 • Number of events 6 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
8.6%
13/152 • Number of events 14 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
9.3%
7/75 • Number of events 7 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
10.4%
8/77 • Number of events 8 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
9.9%
15/152 • Number of events 15 • Up to 37 months
The all participants as treated (APaT) population will be used for the analysis of safety data in this study. The APaT population consists of all randomized participants who received at least one dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER