Trial Outcomes & Findings for An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma (NCT NCT04586244)
NCT ID: NCT04586244
Last Updated: 2025-10-30
Results Overview
Fold Change from Baseline in CD8+ lymphocytes = CD8+ Lymphocytes at cystectomy divided by CD8+ lymphocytes at Screening. Translational data in all but the retifanlimab 500 mg Q4W treatment group were limited and insufficient to assess this outcome measure.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
up to 69 days
Results posted on
2025-10-30
Participant Flow
Participants were enrolled at 2 study centers in the United States, 2 study centers in Italy, and 1 study center in France.
Participant milestones
| Measure |
Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W
Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Epacadostat 600 mg BID
Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W + INCAGN02390 400 mg Q2W
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
20
|
2
|
4
|
1
|
|
Overall Study
COMPLETED
|
2
|
19
|
2
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W
Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Epacadostat 600 mg BID
Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W + INCAGN02390 400 mg Q2W
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Surgery Delayed 140 Days Post-Last Dose Due to AE; Follow-up Data Not Collected
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W
n=3 Participants
Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W
n=20 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Epacadostat 600 mg BID
n=2 Participants
Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
n=4 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W + INCAGN02390 400 mg Q2W
n=1 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
75.7 years
STANDARD_DEVIATION 6.66 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 6.08 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 1.41 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 3.86 • n=4 Participants
|
NA years
STANDARD_DEVIATION NA • n=21 Participants
|
NA years
STANDARD_DEVIATION NA • n=8 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Male
|
3 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Cannot Be Reported Due to Participant Privacy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
2 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Cannot Be Reported Due to Participant Privacy
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: up to 69 daysPopulation: Translation Evaluable Population: all participants who enrolled in the study who received at least 4 weeks of neoadjuvant study treatment (needed to receive the last dose of epacadostat within 2 days prior to the day of surgery or needed to receive the last dose of retifanlimab and/or INCAGN02385 and/or INCAGN02390 within the 7 weeks prior to day of surgery) and provided evaluable paired biopsies (pretreatment core biopsy and surgical resection biopsy)
Fold Change from Baseline in CD8+ lymphocytes = CD8+ Lymphocytes at cystectomy divided by CD8+ lymphocytes at Screening. Translational data in all but the retifanlimab 500 mg Q4W treatment group were limited and insufficient to assess this outcome measure.
Outcome measures
| Measure |
Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W
Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W
n=6 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Epacadostat 600 mg BID
Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W + INCAGN02390 400 mg Q2W
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
|---|---|---|---|---|---|
|
Change From Baseline in CD8+ Lymphocytes Within the Resected Tumor
|
—
|
0.791 log 2 of fold change
Standard Deviation 0.9332
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 159 daysPopulation: Safety Population: all participants who received at least 1 dose of study treatment. Treatment groups were determined according to the actual treatment the participant received regardless of the assigned study treatment.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Outcome measures
| Measure |
Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W
n=3 Participants
Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W
n=20 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Epacadostat 600 mg BID
n=2 Participants
Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
n=4 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W + INCAGN02390 400 mg Q2W
n=1 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
|---|---|---|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
3 Participants
|
18 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 159 daysPopulation: Safety Population
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Outcome measures
| Measure |
Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W
n=3 Participants
Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W
n=20 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Epacadostat 600 mg BID
n=2 Participants
Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
n=4 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W + INCAGN02390 400 mg Q2W
n=1 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
|---|---|---|---|---|---|
|
Number of Participants With Any ≥Grade 3 TEAE
|
2 Participants
|
9 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 69 daysPopulation: Efficacy Population: all participants with secondary efficacy endpoint data available for both Baseline and post-Baseline measurements. The 80% confidence interval was estimated using the Clopper-Pearson method.
Pathological complete response rate was defined as the percentage of participants with ypT0N0.
Outcome measures
| Measure |
Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W
n=2 Participants
Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W
n=20 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Epacadostat 600 mg BID
n=2 Participants
Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
n=4 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W + INCAGN02390 400 mg Q2W
n=1 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
|---|---|---|---|---|---|
|
Pathological Complete Response Rate
|
100 percentage of participants
Interval 31.62 to 100.0
|
40 percentage of participants
Interval 24.91 to 56.73
|
0 percentage of participants
Interval 0.0 to 68.38
|
0 percentage of participants
Interval 0.0 to 43.77
|
100 percentage of participants
Interval 10.0 to 100.0
|
SECONDARY outcome
Timeframe: up to 69 daysPopulation: Efficacy Population. The 80% confidence interval was estimated using the Clopper-Pearson method.
Major pathological response was defined as the percentage of participants with residual ypT0/1/a/isN0M0.
Outcome measures
| Measure |
Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W
n=2 Participants
Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W
n=20 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Epacadostat 600 mg BID
n=2 Participants
Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
n=4 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W + INCAGN02390 400 mg Q2W
n=1 Participants
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
|---|---|---|---|---|---|
|
Major Pathological Response
|
100 percentage of participants
Interval 31.62 to 100.0
|
50 percentage of participants
Interval 33.82 to 66.18
|
50 percentage of participants
Interval 5.13 to 94.87
|
50 percentage of participants
Interval 14.26 to 85.74
|
100 percentage of participants
Interval 10.0 to 100.0
|
Adverse Events
Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Retifanlimab 500 mg Q4W
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Epacadostat 600 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W + INCAGN02390 400 mg Q2W
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W
n=3 participants at risk
Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W
n=20 participants at risk
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Epacadostat 600 mg BID
n=2 participants at risk
Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
n=4 participants at risk
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W + INCAGN02390 400 mg Q2W
n=1 participants at risk
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W
n=3 participants at risk
Participants received oral epacadostat 600 milligrams (mg) twice daily (BID) + intravenous retifanlimab 500 mg every 4 weeks (Q4W; on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W
n=20 participants at risk
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Epacadostat 600 mg BID
n=2 participants at risk
Participants received oral epacadostat 600 mg BID. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W
n=4 participants at risk
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg every 2 weeks (Q2W). Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
Retifanlimab 500 mg Q4W + INCAGN02385 350 mg Q2W + INCAGN02390 400 mg Q2W
n=1 participants at risk
Participants received intravenous retifanlimab 500 mg Q4W (on Day 1 of each 28-day cycle) + intravenous INCAGN02385 350 mg Q2W + intravenous INCAGN02390 400 mg Q2W. Treatment continued for 4 to 10 weeks, as long as participants did not meet any criteria for study withdrawal.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
5/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
15.0%
3/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Aerophagia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
75.0%
3/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
General disorders
Fatigue
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
15.0%
3/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
75.0%
3/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
General disorders
Hyperpyrexia
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
5/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
15.0%
3/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
10.0%
2/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
1/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Carbon dioxide increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Inflammatory marker increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
10.0%
2/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
10.0%
2/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
10.0%
2/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
10.0%
2/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
50.0%
2/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Epididymal tenderness
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
25.0%
1/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
10.0%
2/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
10.0%
2/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
5.0%
1/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
100.0%
1/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
20.0%
4/20 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/2 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/4 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
0.00%
0/1 • up to 159 days
Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study treatment.
|
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