Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis (NCT NCT04048876)
NCT ID: NCT04048876
Last Updated: 2023-06-07
Results Overview
Percentage of participants who achieve a ≥1 stage improvement in liver fibrosis using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≤ -1 from baseline in fibrosis stage is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4) * Stage 0 - None; * Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis; * Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis; * Stage 1c - Portal/periportal fibrosis only; * Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis; * Stage 3 - Bridging fibrosis; * Stage 4 - Cirrhosis.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
From baseline up to week 52
Results posted on
2023-06-07
Participant Flow
Participant milestones
| Measure |
CC-90001 100mg
CC-90001 100 mg PO QD
|
CC-90001 200mg
CC-90001 200 mg PO QD
|
CC-90001 400mg
CC-90001 400 mg PO QD
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Placebo Controlled Phase
STARTED
|
13
|
15
|
13
|
15
|
|
Placebo Controlled Phase
Continuing to Follow Up
|
7
|
12
|
8
|
11
|
|
Placebo Controlled Phase
COMPLETED
|
2
|
0
|
3
|
2
|
|
Placebo Controlled Phase
NOT COMPLETED
|
11
|
15
|
10
|
13
|
|
Active Treatment Phase
STARTED
|
2
|
0
|
3
|
2
|
|
Active Treatment Phase
Placebo to CC-90001 200mg
|
0
|
0
|
0
|
1
|
|
Active Treatment Phase
Placebo to CC-90001 400mg
|
0
|
0
|
0
|
1
|
|
Active Treatment Phase
COMPLETED
|
0
|
0
|
0
|
0
|
|
Active Treatment Phase
NOT COMPLETED
|
2
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
CC-90001 100mg
CC-90001 100 mg PO QD
|
CC-90001 200mg
CC-90001 200 mg PO QD
|
CC-90001 400mg
CC-90001 400 mg PO QD
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Placebo Controlled Phase
Withdrawal by Subject
|
1
|
2
|
0
|
1
|
|
Placebo Controlled Phase
Study Terminated by Sponsor
|
10
|
12
|
10
|
12
|
|
Placebo Controlled Phase
Adverse Event
|
0
|
1
|
0
|
0
|
|
Active Treatment Phase
Study Terminated by Sponsor
|
2
|
0
|
3
|
2
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Baseline characteristics by cohort
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.2 Years
STANDARD_DEVIATION 12.37 • n=5 Participants
|
58.3 Years
STANDARD_DEVIATION 9.92 • n=7 Participants
|
52.1 Years
STANDARD_DEVIATION 11.91 • n=5 Participants
|
60.5 Years
STANDARD_DEVIATION 8.20 • n=4 Participants
|
56.0 Years
STANDARD_DEVIATION 10.98 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From baseline up to week 52Population: Full Analysis Set
Percentage of participants who achieve a ≥1 stage improvement in liver fibrosis using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≤ -1 from baseline in fibrosis stage is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4) * Stage 0 - None; * Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis; * Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis; * Stage 1c - Portal/periportal fibrosis only; * Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis; * Stage 3 - Bridging fibrosis; * Stage 4 - Cirrhosis.
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieve a ≥1 Stage Improvement in Liver Fibrosis Using the NASH CRN Histological Scoring System at Week 52
|
15.4 Percentage of Participants
Interval 1.92 to 45.45
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
7.7 Percentage of Participants
Interval 0.19 to 36.03
|
6.7 Percentage of Participants
Interval 0.17 to 31.95
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Full Analysis Set
Percentage of participants with no worsening of steatohepatitis and ≥1 stage improvement in liver fibrosis score at week 52 using the NASH CRN Histological Scoring System at Week 52. A participant with a change of ≥ -1 from baseline in fibrosis stage and no worsening in steatohepatitis is considered as an improvement responder for this endpoint. The NASH CRN Histologic Scoring System comprised: steatosis (0 to 3) lobular inflammation (0 to 3) hepatocellular ballooning (0 to 2) fibrosis disease stage (0 to 4) * Stage 0 - None; * Stage 1a - Mild (delicate) zone 3 perisinusoidal fibrosis; * Stage 1b - Moderate (dense) zone 3 perisinusoidal fibrosis; * Stage 1c - Portal/periportal fibrosis only; * Stage 2 - Zone 3 perisinusoidal fibrosis with portal/periportal fibrosis; * Stage 3 - Bridging fibrosis; * Stage 4 - Cirrhosis.
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Percentage of Participants With no Worsening of Steatohepatitis and ≥1 Stage Improvement in Liver Fibrosis Score at Week 52
|
15.4 Percentage of Participants
Interval 1.92 to 45.45
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
7.7 Percentage of Participants
Interval 0.19 to 36.03
|
6.7 Percentage of Participants
Interval 0.17 to 31.95
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Full Analysis Set
Percentage of participants with an improvement of ≥ 2 points in the total NAS with improvement in more than one category of steatosis, lobular inflammation, and hepatocellular ballooning, and no worsening of liver fibrosis at Week 52. A participant with a change of ≤ -2 from baseline in total NAS, a change of ≤ -1 from baseline in more than one subscore, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Percentage of Participants With Improvement in Total NAS
|
7.7 Percentage of Participants
Interval 0.19 to 36.03
|
6.7 Percentage of Participants
Interval 0.17 to 31.95
|
15.4 Percentage of Participants
Interval 1.92 to 45.45
|
13.3 Percentage of Participants
Interval 1.66 to 40.46
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Full Analysis Set
Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 at Week 52. Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation is considered as a responder for this endpoint.
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Percentage of Participants With Resolution of NASH
|
15.4 Percentage of Participants
Interval 1.92 to 45.45
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
7.7 Percentage of Participants
Interval 0.19 to 36.03
|
6.7 Percentage of Participants
Interval 0.17 to 31.95
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Full Analysis Set
Percentage of participants who demonstrate absence of ballooning, and lobular inflammation score of 0 or 1 and no worsening of liver fibrosis at Week 52 Absence of ballooning is defined as a score of 0 in hepatocellular ballooning. Worsening of fibrosis stage was defined as progression of NASH CRN fibrosis stage. A participant with a score of 0 in ballooning, a score of 0 or 1 in lobular inflammation, and a change of ≤ 0 from baseline in fibrosis stage is considered as a responder for this endpoint.
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Percentage of Participants With Resolution of NASH With no Worsening of Liver Fibrosis
|
15.4 Percentage of Participants
Interval 1.92 to 45.45
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
7.7 Percentage of Participants
Interval 0.19 to 36.03
|
6.7 Percentage of Participants
Interval 0.17 to 31.95
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Full Analysis Set
Percentage of participants who progressed to cirrhosis
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Percentage of Participants Who Progressed to Cirrhosis
|
0 Percentage of Participants
Interval 0.0 to 24.71
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
7.7 Percentage of Participants
Interval 0.19 to 36.03
|
6.7 Percentage of Participants
Interval 0.17 to 31.95
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Full Analysis Set Population at Week 52 with evaluable measures
Mean change from Baseline in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT)
Outcome measures
| Measure |
CC-90001 100mg
n=2 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=3 Participants
CC-90001 400 mg PO QD
|
Placebo
n=2 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Mean Change From Baseline in Liver Biochemistry
ALT (U/L)
|
26.0 U/L
Standard Deviation 19.80
|
—
|
-22.3 U/L
Standard Deviation 14.19
|
-6.5 U/L
Standard Deviation 21.92
|
|
Mean Change From Baseline in Liver Biochemistry
AST (U/L)
|
9.5 U/L
Standard Deviation 10.61
|
—
|
-17.0 U/L
Standard Deviation 10.15
|
7.0 U/L
Standard Deviation 4.24
|
|
Mean Change From Baseline in Liver Biochemistry
GGT (U/L)
|
13.0 U/L
Standard Deviation 28.28
|
—
|
-6.3 U/L
Standard Deviation 5.86
|
2.5 U/L
Standard Deviation 58.69
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Full Analysis Set Population at Week 52 with evaluable measures
Mean change from baseline in total low density cholesterol (LDL) high density cholesterol (HDL), and triglycerides
Outcome measures
| Measure |
CC-90001 100mg
n=2 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=3 Participants
CC-90001 400 mg PO QD
|
Placebo
n=2 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Mean Change From Baseline in Metabolic Parameters
HDL (mmol/L)
|
0.005 mmol/L
Standard Deviation 0.0354
|
—
|
0.147 mmol/L
Standard Deviation 0.2155
|
0.120 mmol/L
Standard Deviation 0.2687
|
|
Mean Change From Baseline in Metabolic Parameters
LDL (mmol/L)
|
0.970 mmol/L
Standard Deviation 0.4525
|
—
|
0.623 mmol/L
Standard Deviation 0.3785
|
-1.395 mmol/L
Standard Deviation 1.3223
|
|
Mean Change From Baseline in Metabolic Parameters
Triglycerides (mmol/L)
|
-0.135 mmol/L
Standard Deviation 0.0495
|
—
|
0.027 mmol/L
Standard Deviation 0.2650
|
-0.805 mmol/L
Standard Deviation 0.5445
|
SECONDARY outcome
Timeframe: Day 1 and at Week 4Population: PK evaluable population
Cmax is defined as maximum plasma concentration of the drug
Outcome measures
| Measure |
CC-90001 100mg
n=1 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=2 Participants
CC-90001 400 mg PO QD
|
Placebo
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Cmax
Day 1
|
501.0 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate
|
—
|
2938.8 ng/mL
Geometric Coefficient of Variation 44.94
|
—
|
|
Cmax
Week 4
|
352.0 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate
|
—
|
2610.0 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate
|
—
|
SECONDARY outcome
Timeframe: Day 1 and at Week 4Population: PK evaluable population
Tmax is defined is the time to maximum plasma concentration
Outcome measures
| Measure |
CC-90001 100mg
n=1 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=2 Participants
CC-90001 400 mg PO QD
|
Placebo
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Tmax
Day 1
|
2.0 hours
Interval 2.0 to 2.0
|
—
|
2.0 hours
Interval 2.0 to 2.0
|
—
|
|
Tmax
Week 4
|
2.0 hours
Interval 2.0 to 2.0
|
—
|
4.0 hours
Interval 4.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 and at Week 4Population: PK evaluable population
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration
Outcome measures
| Measure |
CC-90001 100mg
n=1 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=2 Participants
CC-90001 400 mg PO QD
|
Placebo
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
AUC (0-t)
Day 1
|
2322.7 h*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate
|
—
|
26803.9 h*ng/mL
Geometric Coefficient of Variation 62.87
|
—
|
|
AUC (0-t)
Week 4
|
2530.5 h*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate
|
—
|
20918.8 h*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate
|
—
|
SECONDARY outcome
Timeframe: Day 1 and at Week 4Population: PK evaluable population
Area under the plasma concentration time-curve. AUC over the dosing interval.
Outcome measures
| Measure |
CC-90001 100mg
n=1 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=2 Participants
CC-90001 400 mg PO QD
|
Placebo
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
AUC t
Day 1
|
2322.7 h*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate
|
—
|
27173.7 h*ng/mL
Geometric Coefficient of Variation 59.71
|
—
|
|
AUC t
Week 4
|
2530.5 h*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate
|
—
|
21182.1 h*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate
|
—
|
SECONDARY outcome
Timeframe: At Week 4Population: PK evaluable population
Apparent total body clearance of the drug (CL/F)
Outcome measures
| Measure |
CC-90001 100mg
n=1 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=2 Participants
CC-90001 400 mg PO QD
|
Placebo
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Apparent Total Body Clearance of the Drug
|
39.5 L/h
Geometric Coefficient of Variation NA
Insufficient number of participants with samples to calculate geometric coefficient of variation
|
—
|
18.9 L/h
Geometric Coefficient of Variation NA
Insufficient number of participants with samples to calculate geometric coefficient of variation
|
—
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Safety Population
Number of participants with treatment related safety events
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Number of Participants With Treatment Related Safety Events
Participants with at least one TEAE
|
10 participants
|
13 participants
|
12 participants
|
10 participants
|
|
Number of Participants With Treatment Related Safety Events
Participants with at least one TEAE related to study drug
|
4 participants
|
5 participants
|
10 participants
|
3 participants
|
|
Number of Participants With Treatment Related Safety Events
Participants with at least one serious TEAE
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Treatment Related Safety Events
Participants with at least one serious TEAE related to study drug
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment Related Safety Events
Participants with at least one grade 3/4 TEAE
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Treatment Related Safety Events
Participants with at least one grade 3/4 TEAE related to study drug
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment Related Safety Events
Participants with at least one TEAE leading to dose interruption
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Treatment Related Safety Events
Participants with at least one TEAE leading to being withdrawn from study drug
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Safety Population
Mean change from baseline in PR interval PR Interval: Atrial depolarization and conduction through the AV node Normal Range: 0.12 - 0.20 (120 to 200 msec)
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Mean Change From Baseline of ECG Results - PR Intervals
Week 4
|
5.8 msec
Standard Deviation 10.42
|
-5.5 msec
Standard Deviation 10.18
|
3.6 msec
Standard Deviation 14.84
|
5.0 msec
Standard Deviation 19.24
|
|
Mean Change From Baseline of ECG Results - PR Intervals
Week 12
|
5.7 msec
Standard Deviation 10.32
|
-2.3 msec
Standard Deviation 10.01
|
2.3 msec
Standard Deviation 21.02
|
15.2 msec
Standard Deviation 26.99
|
|
Mean Change From Baseline of ECG Results - PR Intervals
Week 24
|
4.4 msec
Standard Deviation 7.46
|
-2.8 msec
Standard Deviation 3.90
|
-3.7 msec
Standard Deviation 8.99
|
3.2 msec
Standard Deviation 12.75
|
|
Mean Change From Baseline of ECG Results - PR Intervals
Week 52
|
-7.0 msec
Standard Deviation 9.90
|
—
|
-7.7 msec
Standard Deviation 27.06
|
13.5 msec
Standard Deviation 10.61
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Safety Population
Mean change from baseline in QRS duration QRS Duration: Ventricular depolarization and atrial repolarization Normal Range: 0.08 to 0.10 (80 to 100 msec)
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Mean Change From Baseline of ECG Results - QRS Duration
Week 4
|
0.8 msec
Standard Deviation 2.93
|
0.1 msec
Standard Deviation 5.79
|
-0.1 msec
Standard Deviation 6.90
|
-1.2 msec
Standard Deviation 3.59
|
|
Mean Change From Baseline of ECG Results - QRS Duration
Week 12
|
4.0 msec
Standard Deviation 3.77
|
0.7 msec
Standard Deviation 3.56
|
-2.5 msec
Standard Deviation 5.38
|
-2.8 msec
Standard Deviation 3.11
|
|
Mean Change From Baseline of ECG Results - QRS Duration
Week 24
|
-8.7 msec
Standard Deviation 16.54
|
0.6 msec
Standard Deviation 4.77
|
-2.7 msec
Standard Deviation 3.77
|
-1.0 msec
Standard Deviation 3.90
|
|
Mean Change From Baseline of ECG Results - QRS Duration
Week 52
|
-5.5 msec
Standard Deviation 7.78
|
—
|
-1.3 msec
Standard Deviation 4.16
|
1.0 msec
Standard Deviation 7.07
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Safety Population
Mean change from baseline in QT interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Mean Change From Baseline of ECG Results - QT Interval
Week 4
|
0.4 msec
Standard Deviation 19.71
|
-7.6 msec
Standard Deviation 12.52
|
-0.5 msec
Standard Deviation 9.47
|
1.0 msec
Standard Deviation 13.48
|
|
Mean Change From Baseline of ECG Results - QT Interval
Week 12
|
10.6 msec
Standard Deviation 24.57
|
-9.8 msec
Standard Deviation 15.48
|
-2.0 msec
Standard Deviation 27.22
|
-3.3 msec
Standard Deviation 17.33
|
|
Mean Change From Baseline of ECG Results - QT Interval
Week 24
|
12.0 msec
Standard Deviation 11.55
|
-11.2 msec
Standard Deviation 12.99
|
0.6 msec
Standard Deviation 22.10
|
13.5 msec
Standard Deviation 27.07
|
|
Mean Change From Baseline of ECG Results - QT Interval
Week 52
|
-6.0 msec
Standard Deviation 8.49
|
—
|
-15.3 msec
Standard Deviation 21.73
|
8.0 msec
Standard Deviation 25.46
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Safety Population
Mean change from baseline in QTcB interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec QTc: QT interval corrected based on the patient's heart rate QTcB: An electrocardiographic finding in which the QT interval corrected for heart rate using Bazzett's formula. QTc = QT/√(RR) RR= Respiration Rate
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Mean Change From Baseline of ECG Results - QTcB Interval
Week 4
|
-0.8 msec
Standard Deviation 16.18
|
-2.8 msec
Standard Deviation 17.51
|
-4.0 msec
Standard Deviation 15.18
|
-9.3 msec
Standard Deviation 10.81
|
|
Mean Change From Baseline of ECG Results - QTcB Interval
Week 12
|
-0.3 msec
Standard Deviation 19.75
|
-1.5 msec
Standard Deviation 10.62
|
-9.6 msec
Standard Deviation 22.59
|
1.4 msec
Standard Deviation 9.25
|
|
Mean Change From Baseline of ECG Results - QTcB Interval
Week 24
|
7.9 msec
Standard Deviation 10.75
|
1.2 msec
Standard Deviation 16.41
|
0.7 msec
Standard Deviation 39.65
|
-11.0 msec
Standard Deviation 10.55
|
|
Mean Change From Baseline of ECG Results - QTcB Interval
Week 52
|
-13.0 msec
Standard Deviation 1.41
|
—
|
-35.0 msec
Standard Deviation 9.85
|
4.5 msec
Standard Deviation 14.85
|
SECONDARY outcome
Timeframe: From baseline up to week 52Population: Safety Population
Mean change from baseline in QTcF interval QT Interval: Ventricular depolarization plus ventricular repolarization Normal Range: 400 to 460 msec QTc: QT interval corrected based on the patient's heart rate QTcF: An electrocardiographic finding in which the QT interval corrected for heart rate using Fridericia's formula. QTc = QT/∛(RR) RR = Respiration rate
Outcome measures
| Measure |
CC-90001 100mg
n=13 Participants
CC-90001 100 mg PO QD
|
CC-90001 200mg
n=15 Participants
CC-90001 200 mg PO QD
|
CC-90001 400mg
n=13 Participants
CC-90001 400 mg PO QD
|
Placebo
n=15 Participants
Placebo in placebo controlled phase. CC-90001 100mg, 200mg or 400mg in active treatment extension phase
|
|---|---|---|---|---|
|
Mean Change From Baseline of ECG Results - QTcF Interval
Week 4
|
-3.9 msec
Standard Deviation 15.33
|
-3.5 msec
Standard Deviation 14.45
|
-1.4 msec
Standard Deviation 12.06
|
-4.0 msec
Standard Deviation 10.53
|
|
Mean Change From Baseline of ECG Results - QTcF Interval
Week 12
|
1.0 msec
Standard Deviation 12.33
|
-4.6 msec
Standard Deviation 6.43
|
-6.3 msec
Standard Deviation 21.54
|
-1.4 msec
Standard Deviation 11.24
|
|
Mean Change From Baseline of ECG Results - QTcF Interval
Week 24
|
9.4 msec
Standard Deviation 8.71
|
-3.0 msec
Standard Deviation 10.49
|
-0.9 msec
Standard Deviation 30.17
|
2.2 msec
Standard Deviation 12.67
|
|
Mean Change From Baseline of ECG Results - QTcF Interval
Week 52
|
-11.5 msec
Standard Deviation 3.54
|
—
|
-27.7 msec
Standard Deviation 7.77
|
5.5 msec
Standard Deviation 0.71
|
Adverse Events
CC-90001 100 mg
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
CC-90001 200 mg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
CC-90001 400 mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Active Treatment Phase CC-90001 200 mg Following Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Active Treatment Phase CC-90001 400 mg Following Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CC-90001 100 mg
n=13 participants at risk
CC-90001 100 mg PO QD
|
CC-90001 200 mg
n=15 participants at risk
CC-90001 200 mg PO QD
|
CC-90001 400 mg
n=13 participants at risk
CC-90001 400 mg PO QD
|
Placebo
n=15 participants at risk
Placebo
|
Active Treatment Phase CC-90001 200 mg Following Placebo
n=1 participants at risk
CC-90001 200 mg PO QD
|
Active Treatment Phase CC-90001 400 mg Following Placebo
n=1 participants at risk
CC-90001 400 mg PO QD
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Appendicitis
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Spinal retrolisthesis
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
CC-90001 100 mg
n=13 participants at risk
CC-90001 100 mg PO QD
|
CC-90001 200 mg
n=15 participants at risk
CC-90001 200 mg PO QD
|
CC-90001 400 mg
n=13 participants at risk
CC-90001 400 mg PO QD
|
Placebo
n=15 participants at risk
Placebo
|
Active Treatment Phase CC-90001 200 mg Following Placebo
n=1 participants at risk
CC-90001 200 mg PO QD
|
Active Treatment Phase CC-90001 400 mg Following Placebo
n=1 participants at risk
CC-90001 400 mg PO QD
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Allergic eosinophilia
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.4%
2/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
2/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.3%
2/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Large intestine polyp
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
46.2%
6/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.3%
2/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Injection site pain
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pain
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Appendicitis
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.8%
4/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cystitis
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Hordeolum
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nail bed infection
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.3%
2/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Liver function test increased
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Occult blood positive
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
SARS-CoV-2 test positive
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Urine cytology abnormal
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight increased
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Carpal tunnel syndrome
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.3%
2/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.8%
4/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
3/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Haematuria
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
1/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Haematoma
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
1/13 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/15 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Treatment-emergent adverse events: up to 108 weeks All-cause mortality: participants were assessed from date of randomization to study completion. All-Cause Mortality: up to 108 weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60