Trial Outcomes & Findings for Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma (NCT NCT03374488)
NCT ID: NCT03374488
Last Updated: 2025-08-22
Results Overview
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
84 participants
Primary outcome timeframe
up to 9 weeks +14 days
Results posted on
2025-08-22
Participant Flow
This study was conducted at 82 centers in 16 countries.
Participant milestones
| Measure |
Pembrolizumab 200 mg + Epacadostat 100 mg BID
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Epacadostat administered orally twice daily.
|
Pembrolizumab 200 mg + Placebo BID
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Matching placebo administered orally twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
Intention-to-Treat (ITT)
|
42
|
42
|
|
Overall Study
All Participants as Treated (APaT)
|
42
|
41
|
|
Overall Study
COMPLETED
|
23
|
28
|
|
Overall Study
NOT COMPLETED
|
19
|
14
|
Reasons for withdrawal
| Measure |
Pembrolizumab 200 mg + Epacadostat 100 mg BID
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Epacadostat administered orally twice daily.
|
Pembrolizumab 200 mg + Placebo BID
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Matching placebo administered orally twice daily.
|
|---|---|---|
|
Overall Study
Death
|
13
|
13
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Physician Decision
|
3
|
0
|
Baseline Characteristics
Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Pembrolizumab 200 mg + Epacadostat 100 mg BID
n=42 Participants
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Epacadostat administered orally twice daily.
|
Pembrolizumab 200 mg + Placebo BID
n=42 Participants
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Matching placebo administered orally twice daily.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
65.2 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Metastasis Status at Screening
Metastatic
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Metastasis Status at Screening
Advanced/Unresectable
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 9 weeks +14 daysPopulation: The Intention-to-Treat (ITT) population consisted of all randomized participants. Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to week 9 (day 63) + 14 days.
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.
Outcome measures
| Measure |
Pembrolizumab 200 mg + Epacadostat 100 mg BID
n=42 Participants
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Epacadostat administered orally twice daily.
|
Pembrolizumab 200 mg + Placebo BID
n=42 Participants
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Matching placebo administered orally twice daily.
|
|---|---|---|
|
Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo
|
21.4 percentage of participants
Interval 12.49 to 43.26
|
9.5 percentage of participants
Interval 3.11 to 26.06
|
SECONDARY outcome
Timeframe: Up to 8 monthsPopulation: All Participants as Treated (APaT) population consisted of all randomized participants who received at least 1 dose of study treatment.
AE 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 200 mg + Epacadostat 100 mg BID
n=42 Participants
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Epacadostat administered orally twice daily.
|
Pembrolizumab 200 mg + Placebo BID
n=41 Participants
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Matching placebo administered orally twice daily.
|
|---|---|---|
|
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs)
|
42 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Up to 8 monthsPopulation: All Participants as Treated (APaT) population consisted of all randomized participants who received at least 1 dose of study treatment.
AE 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 200 mg + Epacadostat 100 mg BID
n=42 Participants
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Epacadostat administered orally twice daily.
|
Pembrolizumab 200 mg + Placebo BID
n=41 Participants
Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. Matching placebo administered orally twice daily.
|
|---|---|---|
|
Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE
|
4 Participants
|
6 Participants
|
Adverse Events
MK-3475 200 mg Q3W + Epacad
Serious events: 22 serious events
Other events: 39 other events
Deaths: 14 deaths
MK-3475 200 mg Q3W + Placeb
Serious events: 16 serious events
Other events: 35 other events
Deaths: 18 deaths
Total
Serious events: 38 serious events
Other events: 74 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
MK-3475 200 mg Q3W + Epacad
n=42 participants at risk
MK-3475 200 mg Q3W + epacad
|
MK-3475 200 mg Q3W + Placeb
n=41 participants at risk
MK-3475 200 mg Q3W + placeb
|
Total
n=83 participants at risk
Total
|
|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/42 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Investigations
Amylase increased
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
2.4%
2/83 • Number of events 2 • Up to 8 months
|
|
Nervous system disorders
Ataxia
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Infections and infestations
Bacteraemia
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/42 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/42 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
General disorders
Disease progression
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Gastrointestinal disorders
Diverticular perforation
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/42 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Renal and urinary disorders
Haematuria
|
4.8%
2/42 • Number of events 2 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
3.6%
3/83 • Number of events 3 • Up to 8 months
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/42 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Renal and urinary disorders
Hydronephrosis
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/42 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Gastrointestinal disorders
Ileus
|
4.8%
2/42 • Number of events 2 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
2.4%
2/83 • Number of events 2 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
21.4%
9/42 • Number of events 10 • Up to 8 months
|
14.6%
6/41 • Number of events 6 • Up to 8 months
|
18.1%
15/83 • Number of events 16 • Up to 8 months
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
2.4%
2/83 • Number of events 2 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/42 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Infections and infestations
Pyelonephritis
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/42 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Infections and infestations
Sepsis
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/42 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
|
Infections and infestations
Urinary tract infection
|
7.1%
3/42 • Number of events 5 • Up to 8 months
|
7.3%
3/41 • Number of events 5 • Up to 8 months
|
7.2%
6/83 • Number of events 10 • Up to 8 months
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/42 • Up to 8 months
|
2.4%
1/41 • Number of events 2 • Up to 8 months
|
1.2%
1/83 • Number of events 2 • Up to 8 months
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
1.2%
1/83 • Number of events 1 • Up to 8 months
|
Other adverse events
| Measure |
MK-3475 200 mg Q3W + Epacad
n=42 participants at risk
MK-3475 200 mg Q3W + epacad
|
MK-3475 200 mg Q3W + Placeb
n=41 participants at risk
MK-3475 200 mg Q3W + placeb
|
Total
n=83 participants at risk
Total
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
6/42 • Number of events 7 • Up to 8 months
|
4.9%
2/41 • Number of events 2 • Up to 8 months
|
9.6%
8/83 • Number of events 9 • Up to 8 months
|
|
Investigations
Amylase increased
|
9.5%
4/42 • Number of events 4 • Up to 8 months
|
4.9%
2/41 • Number of events 4 • Up to 8 months
|
7.2%
6/83 • Number of events 8 • Up to 8 months
|
|
Blood and lymphatic system disorders
Anaemia
|
26.2%
11/42 • Number of events 15 • Up to 8 months
|
22.0%
9/41 • Number of events 9 • Up to 8 months
|
24.1%
20/83 • Number of events 24 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
4/42 • Number of events 4 • Up to 8 months
|
4.9%
2/41 • Number of events 3 • Up to 8 months
|
7.2%
6/83 • Number of events 7 • Up to 8 months
|
|
General disorders
Asthenia
|
9.5%
4/42 • Number of events 5 • Up to 8 months
|
17.1%
7/41 • Number of events 10 • Up to 8 months
|
13.3%
11/83 • Number of events 15 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
4/42 • Number of events 4 • Up to 8 months
|
9.8%
4/41 • Number of events 5 • Up to 8 months
|
9.6%
8/83 • Number of events 9 • Up to 8 months
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
3/42 • Number of events 3 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
4.8%
4/83 • Number of events 4 • Up to 8 months
|
|
Investigations
Blood creatinine increased
|
9.5%
4/42 • Number of events 4 • Up to 8 months
|
7.3%
3/41 • Number of events 3 • Up to 8 months
|
8.4%
7/83 • Number of events 7 • Up to 8 months
|
|
General disorders
Chest pain
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
9.8%
4/41 • Number of events 4 • Up to 8 months
|
6.0%
5/83 • Number of events 5 • Up to 8 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
14/42 • Number of events 16 • Up to 8 months
|
14.6%
6/41 • Number of events 6 • Up to 8 months
|
24.1%
20/83 • Number of events 22 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.9%
5/42 • Number of events 5 • Up to 8 months
|
4.9%
2/41 • Number of events 2 • Up to 8 months
|
8.4%
7/83 • Number of events 7 • Up to 8 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.0%
13/42 • Number of events 15 • Up to 8 months
|
14.6%
6/41 • Number of events 6 • Up to 8 months
|
22.9%
19/83 • Number of events 21 • Up to 8 months
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
9/42 • Number of events 15 • Up to 8 months
|
9.8%
4/41 • Number of events 5 • Up to 8 months
|
15.7%
13/83 • Number of events 20 • Up to 8 months
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
3/42 • Number of events 3 • Up to 8 months
|
2.4%
1/41 • Number of events 2 • Up to 8 months
|
4.8%
4/83 • Number of events 5 • Up to 8 months
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
3/42 • Number of events 3 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
3.6%
3/83 • Number of events 3 • Up to 8 months
|
|
Renal and urinary disorders
Dysuria
|
9.5%
4/42 • Number of events 4 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
6.0%
5/83 • Number of events 5 • Up to 8 months
|
|
General disorders
Fatigue
|
31.0%
13/42 • Number of events 13 • Up to 8 months
|
12.2%
5/41 • Number of events 5 • Up to 8 months
|
21.7%
18/83 • Number of events 18 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
9.5%
4/42 • Number of events 4 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
4.8%
4/83 • Number of events 4 • Up to 8 months
|
|
Renal and urinary disorders
Haematuria
|
19.0%
8/42 • Number of events 9 • Up to 8 months
|
7.3%
3/41 • Number of events 3 • Up to 8 months
|
13.3%
11/83 • Number of events 12 • Up to 8 months
|
|
Nervous system disorders
Headache
|
2.4%
1/42 • Number of events 1 • Up to 8 months
|
9.8%
4/41 • Number of events 4 • Up to 8 months
|
6.0%
5/83 • Number of events 5 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.5%
4/42 • Number of events 5 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
4.8%
4/83 • Number of events 5 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.1%
3/42 • Number of events 3 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
4.8%
4/83 • Number of events 4 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
3/42 • Number of events 3 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
3.6%
3/83 • Number of events 3 • Up to 8 months
|
|
Endocrine disorders
Hypothyroidism
|
9.5%
4/42 • Number of events 4 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
6.0%
5/83 • Number of events 5 • Up to 8 months
|
|
Investigations
Lipase increased
|
11.9%
5/42 • Number of events 10 • Up to 8 months
|
4.9%
2/41 • Number of events 4 • Up to 8 months
|
8.4%
7/83 • Number of events 14 • Up to 8 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.1%
3/42 • Number of events 3 • Up to 8 months
|
4.9%
2/41 • Number of events 6 • Up to 8 months
|
6.0%
5/83 • Number of events 9 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.5%
4/42 • Number of events 5 • Up to 8 months
|
4.9%
2/41 • Number of events 2 • Up to 8 months
|
7.2%
6/83 • Number of events 7 • Up to 8 months
|
|
Gastrointestinal disorders
Nausea
|
23.8%
10/42 • Number of events 12 • Up to 8 months
|
14.6%
6/41 • Number of events 10 • Up to 8 months
|
19.3%
16/83 • Number of events 22 • Up to 8 months
|
|
General disorders
Oedema peripheral
|
7.1%
3/42 • Number of events 3 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
4.8%
4/83 • Number of events 4 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.0%
8/42 • Number of events 9 • Up to 8 months
|
9.8%
4/41 • Number of events 7 • Up to 8 months
|
14.5%
12/83 • Number of events 16 • Up to 8 months
|
|
General disorders
Pyrexia
|
16.7%
7/42 • Number of events 7 • Up to 8 months
|
7.3%
3/41 • Number of events 3 • Up to 8 months
|
12.0%
10/83 • Number of events 10 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.4%
9/42 • Number of events 11 • Up to 8 months
|
9.8%
4/41 • Number of events 6 • Up to 8 months
|
15.7%
13/83 • Number of events 17 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
3/42 • Number of events 3 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
3.6%
3/83 • Number of events 3 • Up to 8 months
|
|
Renal and urinary disorders
Renal impairment
|
9.5%
4/42 • Number of events 4 • Up to 8 months
|
2.4%
1/41 • Number of events 1 • Up to 8 months
|
6.0%
5/83 • Number of events 5 • Up to 8 months
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
3/42 • Number of events 4 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
3.6%
3/83 • Number of events 4 • Up to 8 months
|
|
Infections and infestations
Urinary tract infection
|
16.7%
7/42 • Number of events 13 • Up to 8 months
|
14.6%
6/41 • Number of events 9 • Up to 8 months
|
15.7%
13/83 • Number of events 22 • Up to 8 months
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
6/42 • Number of events 7 • Up to 8 months
|
9.8%
4/41 • Number of events 7 • Up to 8 months
|
12.0%
10/83 • Number of events 14 • Up to 8 months
|
|
Investigations
Weight decreased
|
9.5%
4/42 • Number of events 4 • Up to 8 months
|
0.00%
0/41 • Up to 8 months
|
4.8%
4/83 • Number of events 4 • Up to 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER