Trial Outcomes & Findings for Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events (NCT NCT01968967)
NCT ID: NCT01968967
Last Updated: 2018-07-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2139 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2018-07-31
Participant Flow
This study was conducted at multiple sites from 28 October 2014 to 15 July 2016 for the Treatment Period and up to 10 July 2017 for the Extension Period.
Participant milestones
| Measure |
Placebo (Treatment Period)
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
Participants received Bococizumab (PF-04950615) 150 milligram (mg) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Placebo (Extension Period)
Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.
|
Bococizumab ADA Positive (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
1071
|
1068
|
0
|
0
|
0
|
|
Treatment Period
Treated
|
1065
|
1063
|
0
|
0
|
0
|
|
Treatment Period
COMPLETED
|
925
|
934
|
0
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
146
|
134
|
0
|
0
|
0
|
|
Extension Period
STARTED
|
0
|
0
|
47
|
19
|
39
|
|
Extension Period
COMPLETED
|
0
|
0
|
45
|
19
|
34
|
|
Extension Period
NOT COMPLETED
|
0
|
0
|
2
|
0
|
5
|
Reasons for withdrawal
| Measure |
Placebo (Treatment Period)
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
Participants received Bococizumab (PF-04950615) 150 milligram (mg) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Placebo (Extension Period)
Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.
|
Bococizumab ADA Positive (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|---|---|
|
Treatment Period
Other
|
22
|
22
|
0
|
0
|
0
|
|
Treatment Period
Withdrawal by Subject
|
71
|
61
|
0
|
0
|
0
|
|
Treatment Period
Did Not Meet Entrance Criteria
|
2
|
3
|
0
|
0
|
0
|
|
Treatment Period
Lost to Follow-up
|
26
|
31
|
0
|
0
|
0
|
|
Treatment Period
Protocol Violation
|
1
|
2
|
0
|
0
|
0
|
|
Treatment Period
Adverse Event
|
9
|
8
|
0
|
0
|
0
|
|
Treatment Period
Death
|
9
|
2
|
0
|
0
|
0
|
|
Treatment Period
Randomized Not Treated
|
6
|
5
|
0
|
0
|
0
|
|
Extension Period
Withdrew Consent
|
0
|
0
|
2
|
0
|
5
|
Baseline Characteristics
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
Baseline characteristics by cohort
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52 and were followed up to Week 58.
|
Total
n=2139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
62 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
434 Participants
n=5 Participants
|
434 Participants
n=7 Participants
|
868 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
637 Participants
n=5 Participants
|
634 Participants
n=7 Participants
|
1271 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: FAS included all participants who were randomized. Here, "Number of participants analyzed (N)" signifies number of participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=994 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=980 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
|
1.0 percent change
Standard Deviation 22.55
|
-54.9 percent change
Standard Deviation 26.84
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52
Week 12
|
-0.1 percent change
Standard Deviation 16.18
|
-34.9 percent change
Standard Deviation 18.34
|
—
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52
Week 24
|
1.0 percent change
Standard Deviation 18.68
|
-30.5 percent change
Standard Deviation 21.56
|
—
|
|
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52
Week 52
|
-0.3 percent change
Standard Deviation 18.75
|
-25.3 percent change
Standard Deviation 23.43
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52
Week 12
|
0.4 percent change
Standard Deviation 18.83
|
-50.4 percent change
Standard Deviation 27.42
|
—
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52
Week 24
|
1.5 percent change
Standard Deviation 21.43
|
-44.9 percent change
Standard Deviation 31.17
|
—
|
|
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52
Week 52
|
-0.4 percent change
Standard Deviation 21.78
|
-37.4 percent change
Standard Deviation 32.92
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Week 12
|
0.2 percent change
Standard Deviation 21.22
|
-49.7 percent change
Standard Deviation 25.51
|
—
|
|
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Week 24
|
1.6 percent change
Standard Deviation 24.65
|
-43.8 percent change
Standard Deviation 30.02
|
—
|
|
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Week 52
|
-0.3 percent change
Standard Deviation 24.62
|
-36.8 percent change
Standard Deviation 32.73
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: A subset of FAS included all participants who were randomized and had TG \<200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=791 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=788 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 12
|
1.9 percent change
Standard Deviation 23.07
|
-55.6 percent change
Standard Deviation 26.81
|
—
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 24
|
3.9 percent change
Standard Deviation 27.17
|
-49.2 percent change
Standard Deviation 32.58
|
—
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 52
|
3.2 percent change
Standard Deviation 26.65
|
-40.6 percent change
Standard Deviation 36.45
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: A subset of FAS included all participants who were randomized and had TG \>=200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=280 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=280 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 12
|
-1.5 percent change
Standard Deviation 20.82
|
-53.0 percent change
Standard Deviation 26.90
|
—
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 24
|
1.1 percent change
Standard Deviation 28.21
|
-42.8 percent change
Standard Deviation 31.87
|
—
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 52
|
-1.2 percent change
Standard Deviation 27.78
|
-36.3 percent change
Standard Deviation 34.88
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at the specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52
Week 12
|
2.4 percent change
Standard Deviation 85.08
|
-26.3 percent change
Standard Deviation 42.63
|
—
|
|
Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52
Week 24
|
8.7 percent change
Standard Deviation 146.00
|
-22.7 percent change
Standard Deviation 51.48
|
—
|
|
Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52
Week 52
|
4.3 percent change
Standard Deviation 139.49
|
-20.9 percent change
Standard Deviation 110.14
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Week 12
|
0.4 percent change
Standard Deviation 13.92
|
6.2 percent change
Standard Deviation 14.99
|
—
|
|
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Week 24
|
0.5 percent change
Standard Deviation 15.25
|
6.1 percent change
Standard Deviation 15.32
|
—
|
|
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Week 52
|
1.2 percent change
Standard Deviation 16.09
|
6.5 percent change
Standard Deviation 17.87
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24, 52Population: FAS included all participants who were randomized. Here, "N" signifies number of participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period
Week 24
|
3.2 percent change
Standard Deviation 27.45
|
-47.5 percent change
Standard Deviation 32.50
|
—
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period
Week 52
|
2.1 percent change
Standard Deviation 27.00
|
-39.5 percent change
Standard Deviation 36.08
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52
Week 12
|
3.5 percent change
Standard Deviation 38.25
|
-12.9 percent change
Standard Deviation 39.99
|
—
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52
Week 24
|
5.1 percent change
Standard Deviation 51.06
|
-11.5 percent change
Standard Deviation 41.33
|
—
|
|
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52
Week 52
|
0.3 percent change
Standard Deviation 43.63
|
-12.5 percent change
Standard Deviation 40.82
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Week 12
|
-0.6 percent change
Standard Deviation 11.22
|
2.8 percent change
Standard Deviation 11.73
|
—
|
|
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Week 24
|
-0.9 percent change
Standard Deviation 12.10
|
2.7 percent change
Standard Deviation 11.93
|
—
|
|
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Week 52
|
-1.2 percent change
Standard Deviation 12.34
|
2.6 percent change
Standard Deviation 13.75
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
Week 12
|
-1.2 percent change
Standard Deviation 13.05
|
-1.0 percent change
Standard Deviation 13.75
|
—
|
|
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
Week 24
|
-0.9 percent change
Standard Deviation 13.56
|
0.1 percent change
Standard Deviation 14.28
|
—
|
|
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52
Week 52
|
-2.5 percent change
Standard Deviation 13.50
|
-1.0 percent change
Standard Deviation 13.72
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52
Week 12
|
3.5 percent change
Standard Deviation 38.25
|
-12.9 percent change
Standard Deviation 39.99
|
—
|
|
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52
Week 24
|
5.1 percent change
Standard Deviation 51.06
|
-11.5 percent change
Standard Deviation 41.33
|
—
|
|
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52
Week 52
|
0.3 percent change
Standard Deviation 43.63
|
-12.5 percent change
Standard Deviation 40.82
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: A subset of FAS included all participants who were randomized and had TG \<200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=791 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=788 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12
Baseline
|
109.1 mg/dL
Standard Deviation 33.24
|
107.1 mg/dL
Standard Deviation 30.43
|
—
|
|
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12
Change at Week 12
|
0.3 mg/dL
Standard Deviation 25.70
|
-59.3 mg/dL
Standard Deviation 32.30
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: A subset of FAS included all participants who were randomized and had TG \>=200 mg/dL at pre-randomization. Here, "n" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=280 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=280 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12
Baseline
|
125.9 mg/dL
Standard Deviation 40.08
|
121.5 mg/dL
Standard Deviation 37.84
|
—
|
|
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12
Change at Week 12
|
-3.4 mg/dL
Standard Deviation 29.08
|
-64.8 mg/dL
Standard Deviation 38.94
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Baseline
|
113.5 mg/dL
Standard Deviation 35.90
|
110.9 mg/dL
Standard Deviation 33.13
|
—
|
|
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Change at Week 12
|
-0.7 mg/dL
Standard Deviation 26.66
|
-60.7 mg/dL
Standard Deviation 34.22
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Change at Week 12
|
-1.8 mg/dL
Standard Deviation 31.62
|
-64.5 mg/dL
Standard Deviation 38.01
|
—
|
|
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Baseline
|
186.3 mg/dL
Standard Deviation 40.77
|
183.1 mg/dL
Standard Deviation 38.31
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Baseline
|
138.0 mg/dL
Standard Deviation 39.67
|
135.3 mg/dL
Standard Deviation 36.85
|
—
|
|
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Change at Week 12
|
-1.6 mg/dL
Standard Deviation 30.93
|
-67.0 mg/dL
Standard Deviation 38.89
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12
Baseline
|
94.0 mg/dL
Standard Deviation 24.26
|
92.3 mg/dL
Standard Deviation 22.74
|
—
|
|
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12
Change at Week 12
|
-0.7 mg/dL
Standard Deviation 18.35
|
-46.0 mg/dL
Standard Deviation 26.58
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12
Baseline
|
45.3 mg/dL
Standard Deviation 49.77
|
46.4 mg/dL
Standard Deviation 55.57
|
—
|
|
Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12
Change at Week 12
|
-0.0 mg/dL
Standard Deviation 12.07
|
-10.6 mg/dL
Standard Deviation 18.36
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Baseline
|
48.3 mg/dL
Standard Deviation 12.42
|
47.8 mg/dL
Standard Deviation 12.72
|
—
|
|
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Change at Week 12
|
-0.1 mg/dL
Standard Deviation 6.84
|
2.5 mg/dL
Standard Deviation 7.07
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: FAS included all participants who were randomized. Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Baseline
|
4.1 Ratio
Standard Deviation 1.22
|
4.0 Ratio
Standard Deviation 1.19
|
—
|
|
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Change at Week 12
|
-0.0 Ratio
Standard Deviation 0.86
|
-1.5 Ratio
Standard Deviation 1.09
|
—
|
|
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Change at Week 24
|
0.0 Ratio
Standard Deviation 0.96
|
-1.4 Ratio
Standard Deviation 1.15
|
—
|
|
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
Change at Week 52
|
-0.0 Ratio
Standard Deviation 0.97
|
-1.1 Ratio
Standard Deviation 1.21
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, 24, 52Population: FAS included all participants who were randomized. Here, "n" signifies number of participants evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Baseline
|
0.7 Ratio
Standard Deviation 0.21
|
0.7 Ratio
Standard Deviation 0.20
|
—
|
|
Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Change at Week 12
|
0.0 Ratio
Standard Deviation 0.14
|
-0.3 Ratio
Standard Deviation 0.21
|
—
|
|
Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Change at Week 24
|
0.0 Ratio
Standard Deviation 0.15
|
-0.3 Ratio
Standard Deviation 0.23
|
—
|
|
Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52
Change at Week 52
|
0.0 Ratio
Standard Deviation 0.16
|
-0.2 Ratio
Standard Deviation 0.23
|
—
|
SECONDARY outcome
Timeframe: Week 12, 24, 52Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm respectively.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 12
|
45.3 percentage of participants
|
90.9 percentage of participants
|
—
|
|
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 2
|
43.2 percentage of participants
|
85.8 percentage of participants
|
—
|
|
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 52
|
45.0 percentage of participants
|
79.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 12, 24, 52Population: FAS included all participants who were randomized. Here, 'n' signifies those participants who were evaluable at specified time points for each arm respectively.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1071 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1068 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 52
|
6.8 percentage of participants
|
61.4 percentage of participants
|
—
|
|
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 12
|
5.9 percentage of participants
|
78.6 percentage of participants
|
—
|
|
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52
Week 24
|
7.8 percentage of participants
|
69.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 12, 24, 52Population: Analysis set included participants who received at least 1 dose of PF-04950615. Here, "n" signifies those participants who were evaluable at specified time points.
Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1063 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Plasma Concentration of PF-04950615 at Week 12, 24 and 52
Week 12
|
4.91 Microgram per milliliter
Standard Deviation 4.987
|
—
|
—
|
|
Plasma Concentration of PF-04950615 at Week 12, 24 and 52
Week 24
|
4.74 Microgram per milliliter
Standard Deviation 5.772
|
—
|
—
|
|
Plasma Concentration of PF-04950615 at Week 12, 24 and 52
Week 52
|
3.60 Microgram per milliliter
Standard Deviation 4.685
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 58Population: Safety analysis set included all participants who received at least 1 dose of study treatment.
Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=1065 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1063 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Type 1 or 3 hypersensitivity reactions
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Injection site reactions
|
56 Participants
|
144 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 58Population: Safety analysis population included all participants who received at least 1 dose of study treatment. Here, "N" signifies those participants who were evaluable for this outcome measure for each reporting arm respectively.
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer \>=6.23 (log2) unit was considered to be ADA positive and nAb titer \>=1.58 (log2) unit was considered to be nAb positive.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=231 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1046 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period
Baseline up to Week 58: ADA
|
0.9 Percentage of participants
|
46.7 Percentage of participants
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period
Baseline up to Week 58: nAb
|
0.4 Percentage of participants
|
30.3 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 58 follow-up visit to Week 110Population: All participants who consented for extension period.
In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=47 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=19 Participants
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
n=39 Participants
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Number of Participants Who Changed Concomitant Medication During Extension Period
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 58 follow-up visit, 71, 84, 97, 110Population: All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms: Placebo (Extension Period) and Bococizumab ADA negative (Extension Period). Here, "n" signifies number of participants who were evaluable at specified time points.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=19 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period
Week 110
|
-5.0 percent change
Standard Deviation 28.65
|
—
|
—
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period
Week 58 follow-up visit
|
-6.4 percent change
Standard Deviation 24.67
|
—
|
—
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period
Week 71
|
-10.4 percent change
Standard Deviation 41.51
|
—
|
—
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period
Week 84
|
-15.8 percent change
Standard Deviation 25.65
|
—
|
—
|
|
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period
Week 97
|
-20.8 percent change
Standard Deviation 31.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110Population: All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms Placebo (Extension period) and Bococizumab ADA negative (Extension period). Here, "n" signifies number of participants who were evaluable at specified time points.
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer \>=6.23 (log2) unit was considered to be ADA positive and nAb titer \>=1.58 (log2) unit was considered to be nAb positive.
Outcome measures
| Measure |
Placebo (Treatment Period)
n=19 Participants
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab ADA Negative (Extension Period)
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Week 58 follow-up visit: ADA
|
100.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Week 58 follow-up visit: nAB
|
36.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Week 71: ADA
|
62.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Week 71: nAB
|
31.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Week 84: ADA
|
81.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Week 84: nAB
|
45.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Week 97: ADA
|
50.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Week 97: nAB
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Week 110: ADA
|
85.7 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period
Week 110: nAB
|
57.1 Percentage of participants
|
—
|
—
|
Adverse Events
Placebo (Treatment Period)
Serious events: 150 serious events
Other events: 138 other events
Deaths: 9 deaths
Bococizumab 150 mg (Treatment Period)
Serious events: 116 serious events
Other events: 177 other events
Deaths: 2 deaths
Placebo (Extension Period)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Bococizumab ADA Positive (Extension Period)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Bococizumab ADA Negative (Extension Period)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Treatment Period)
n=1065 participants at risk
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1063 participants at risk
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52 and were followed up to Week 58.
|
Placebo (Extension Period)
n=47 participants at risk
Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.
|
Bococizumab ADA Positive (Extension Period)
n=19 participants at risk
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
Bococizumab ADA Negative (Extension Period)
n=39 participants at risk
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
General disorders
Left leg - severe pain, redness, and induration
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.66%
7/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Angina pectoris
|
0.38%
4/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.75%
8/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Angina unstable
|
0.56%
6/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Aortic valve calcification
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.38%
4/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.38%
4/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Atrial flutter
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Cardiac failure
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.28%
3/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.38%
4/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Cardiomyopathy
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
2.1%
1/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
5.3%
1/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Myocardial infarction
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.38%
4/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.28%
3/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Subvalvular aortic stenosis
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Congenital, familial and genetic disorders
Bartter's syndrome
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Eye disorders
Cataract
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.38%
4/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Colitis
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Food poisoning
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Gastritis
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Gastrointestinal disorders
Volvulus
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
General disorders
Asthenia
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
General disorders
Chest pain
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
General disorders
Death
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
General disorders
Impaired healing
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
General disorders
Non-cardiac chest pain
|
0.28%
3/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.66%
7/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
General disorders
Peripheral swelling
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Hepatobiliary disorders
Biliary colic
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Appendicitis
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Appendicitis perforated
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Bronchitis
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Cellulitis
|
0.47%
5/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.38%
4/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.16%
1/635 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/630 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/31 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/8 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/26 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Device related infection
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Diverticulitis
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Escherichia sepsis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Localised infection
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Osteomyelitis
|
0.28%
3/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Pneumonia
|
0.94%
10/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.28%
3/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Pneumonia bacterial
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Scrotal abscess
|
0.16%
1/635 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/630 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/31 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/8 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/26 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Sepsis
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Sepsis syndrome
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Septic shock
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Sialoadenitis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Staphylococcal infection
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Urinary tract infection
|
0.28%
3/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.38%
4/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.28%
3/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Investigations
Blood creatinine increased
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Investigations
Blood pressure increased
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Investigations
Blood urine present
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Investigations
Electrocardiogram change
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Investigations
Hepatic enzyme increased
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Investigations
Liver function test increased
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Investigations
Troponin increased
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.28%
3/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.28%
3/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.38%
4/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/430 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.23%
1/433 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/16 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/11 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/13 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/430 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.23%
1/433 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/16 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/11 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/13 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.23%
1/430 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/433 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/16 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/11 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/13 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.47%
3/635 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/630 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/31 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/8 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/26 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma recurrent
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.47%
2/430 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/433 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/16 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/11 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/13 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/430 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.23%
1/433 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/16 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/11 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/13 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Aphasia
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.28%
3/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Cervical myelopathy
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Embolic stroke
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Ischaemic stroke
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Mental impairment
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Myelopathy
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Presyncope
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Radiculopathy
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Seizure
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.28%
3/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Syncope
|
0.75%
8/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Psychiatric disorders
Depression
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.28%
3/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Renal and urinary disorders
Renal colic
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Renal and urinary disorders
Renal failure
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Reproductive system and breast disorders
Prostatic haemorrhage
|
0.00%
0/635 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.16%
1/630 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/31 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/8 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/26 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Reproductive system and breast disorders
Scrotal ulcer
|
0.16%
1/635 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/630 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/31 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/8 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/26 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.23%
1/430 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/433 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/16 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/11 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/13 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.28%
3/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.56%
6/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
2.6%
1/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Haematoma
|
0.38%
4/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Hypotension
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Intermittent claudication
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Orthostatic hypotension
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.19%
2/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.19%
2/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Vena cava thrombosis
|
0.09%
1/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.09%
1/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Cardiac disorders
Condition aggravated
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
2.1%
1/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
2.6%
1/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/47 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
0.00%
0/19 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
2.6%
1/39 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
Other adverse events
| Measure |
Placebo (Treatment Period)
n=1065 participants at risk
Participants received placebo matched to Bococizumab (PF-04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to Week 58.
|
Bococizumab 150 mg (Treatment Period)
n=1063 participants at risk
Participants received Bococizumab (PF--04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52 and were followed up to Week 58.
|
Placebo (Extension Period)
n=47 participants at risk
Participants randomized to Placebo arm in treatment period and consented for extension period after Week 58 follow-up visit, were followed for SAEs and concomitant medications up to Week 110.
|
Bococizumab ADA Positive (Extension Period)
n=19 participants at risk
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their ADA assessment at Week 58 follow-up visit. In extension period, participants who were ADA positive and consented for extension period were assessed for ADA and LDL-C direct measurement until ADA titers were no longer detectable or had returned to baseline titer (less than or equal to 1.58 (log2) units above a positive baseline titer) or until Week 110 along with SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
Bococizumab ADA Negative (Extension Period)
n=39 participants at risk
Participants randomized to Bococizumab in treatment period were classified as either ADA positive or ADA negative based on their Week 58 follow-up ADA assessment. Participants who were ADA negative and consented for extension period were followed for SAEs and concomitant medication, from Week 58 follow up visit to Week 110.
|
|---|---|---|---|---|---|
|
General disorders
Injection site reaction
|
2.2%
23/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
9.1%
97/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
—
0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
—
0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
—
0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
60/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
4.7%
50/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
—
0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
—
0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
—
0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
|
Vascular disorders
Hypertension
|
5.7%
61/1065 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
4.4%
47/1063 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
—
0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
—
0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
—
0/0 • For SAEs: Baseline up to Week 110 and for other AEs: Baseline up to Week 58
Event may be serious in 1 and nonserious in other participant or 1 participant may have experienced both serious and nonserious AE. Participants evaluable:treatment period: participants who received at least 1 dose of study drug;extension period: participants who consented for extension period. Nonserious AEs were not collected for extension period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER