Trial Outcomes & Findings for Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT03955146)
NCT ID: NCT03955146
Last Updated: 2024-09-19
Results Overview
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were calculated using mixed model for repeated measures (MMRM).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
393 participants
Primary outcome timeframe
Baseline, Week 48
Results posted on
2024-09-19
Participant Flow
The study included a double-blind (DB) period (main study cohort and Japan extension cohort) and an open-label extension (OLE) period. OLE period was not conducted in Japan. The efficacy outcome measures data were not collected for Japan cohorts due to early termination of study.
Participant milestones
| Measure |
Main Study Cohort: Pamrevlumab
Participants received pamrevlumab 30 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion every 3 weeks for up to 48 weeks in the DB period and continued to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of idiopathic pulmonary fibrosis (IPF), or the sponsor decided to end the OLE period, whichever occurred first.
|
Main Study Cohort: Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period. Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
|
Japan Extension Cohort: Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
Japan Extension Cohort: Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
|---|---|---|---|---|
|
DB Period (48 Weeks)
STARTED
|
181
|
175
|
18
|
19
|
|
DB Period (48 Weeks)
Received at Least 1 Dose of Study Drug
|
181
|
175
|
18
|
19
|
|
DB Period (48 Weeks)
COMPLETED
|
146
|
134
|
14
|
11
|
|
DB Period (48 Weeks)
NOT COMPLETED
|
35
|
41
|
4
|
8
|
|
OLE (Maximum Exposure: 153.1 Weeks)
STARTED
|
129
|
123
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Received at Least 1 Dose of Study Drug
|
129
|
123
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
NOT COMPLETED
|
129
|
123
|
0
|
0
|
Reasons for withdrawal
| Measure |
Main Study Cohort: Pamrevlumab
Participants received pamrevlumab 30 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion every 3 weeks for up to 48 weeks in the DB period and continued to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of idiopathic pulmonary fibrosis (IPF), or the sponsor decided to end the OLE period, whichever occurred first.
|
Main Study Cohort: Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period. Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
|
Japan Extension Cohort: Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
Japan Extension Cohort: Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
|---|---|---|---|---|
|
DB Period (48 Weeks)
Study terminated by sponsor
|
0
|
0
|
1
|
4
|
|
DB Period (48 Weeks)
Adverse Event
|
2
|
5
|
1
|
2
|
|
DB Period (48 Weeks)
Death
|
13
|
17
|
1
|
0
|
|
DB Period (48 Weeks)
Investigator Decision
|
2
|
2
|
0
|
0
|
|
DB Period (48 Weeks)
Disease Progression
|
2
|
0
|
0
|
0
|
|
DB Period (48 Weeks)
Withdrawal by Subject
|
6
|
3
|
0
|
1
|
|
DB Period (48 Weeks)
Noncompliance with the Study Drug
|
1
|
1
|
0
|
0
|
|
DB Period (48 Weeks)
Lung Transplant
|
0
|
1
|
0
|
0
|
|
DB Period (48 Weeks)
Participant Decision
|
9
|
12
|
1
|
1
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Adverse Event
|
7
|
1
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Death
|
12
|
12
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Investigator Decision
|
2
|
2
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Study terminated by sponsor
|
84
|
88
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Disease Progression
|
1
|
0
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Withdrawal by Subject
|
7
|
5
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Lung Transplant
|
2
|
1
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Protocol Deviation
|
1
|
0
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Participant Decision
|
12
|
13
|
0
|
0
|
|
OLE (Maximum Exposure: 153.1 Weeks)
Other than specified
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Per planned analysis, the Baseline characteristics data for 'main study cohort' and 'Japan extension cohort' was collected and reported separately.
Baseline characteristics by cohort
| Measure |
DB Period (Main Study Cohort): Pamrevlumab
n=181 Participants
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the DB period and continued to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
|
DB Period (Main Study Cohort): Placebo
n=175 Participants
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period. Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
|
DB Period (Japan Extension Cohort): Pamrevlumab
n=18 Participants
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Placebo
n=19 Participants
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
Total
n=393 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
≤64 Years
|
41 Participants
n=181 Participants
|
28 Participants
n=175 Participants
|
3 Participants
n=18 Participants
|
5 Participants
n=19 Participants
|
77 Participants
n=393 Participants
|
|
Age, Customized
65 - 74 Years
|
77 Participants
n=181 Participants
|
94 Participants
n=175 Participants
|
10 Participants
n=18 Participants
|
5 Participants
n=19 Participants
|
186 Participants
n=393 Participants
|
|
Age, Customized
≥75 Years
|
63 Participants
n=181 Participants
|
53 Participants
n=175 Participants
|
5 Participants
n=18 Participants
|
9 Participants
n=19 Participants
|
130 Participants
n=393 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=181 Participants
|
49 Participants
n=175 Participants
|
5 Participants
n=18 Participants
|
3 Participants
n=19 Participants
|
106 Participants
n=393 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=181 Participants
|
126 Participants
n=175 Participants
|
13 Participants
n=18 Participants
|
16 Participants
n=19 Participants
|
287 Participants
n=393 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=181 Participants
|
44 Participants
n=175 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
98 Participants
n=393 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=181 Participants
|
131 Participants
n=175 Participants
|
18 Participants
n=18 Participants
|
19 Participants
n=19 Participants
|
295 Participants
n=393 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=181 Participants
|
0 Participants
n=175 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=393 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=181 Participants
|
0 Participants
n=175 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Asian
|
63 Participants
n=181 Participants
|
69 Participants
n=175 Participants
|
18 Participants
n=18 Participants
|
19 Participants
n=19 Participants
|
169 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=181 Participants
|
0 Participants
n=175 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=181 Participants
|
1 Participants
n=175 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=393 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=181 Participants
|
104 Participants
n=175 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
221 Participants
n=393 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=181 Participants
|
0 Participants
n=175 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=393 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=181 Participants
|
1 Participants
n=175 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=393 Participants
|
|
Forced Vital Capacity (FVC)
Main Study Cohort
|
2.3668 liters
STANDARD_DEVIATION 0.6185 • n=181 Participants • Per planned analysis, the Baseline characteristics data for 'main study cohort' and 'Japan extension cohort' was collected and reported separately.
|
2.4161 liters
STANDARD_DEVIATION 0.6453 • n=175 Participants • Per planned analysis, the Baseline characteristics data for 'main study cohort' and 'Japan extension cohort' was collected and reported separately.
|
—
|
—
|
2.3911 liters
STANDARD_DEVIATION 0.6314 • n=356 Participants • Per planned analysis, the Baseline characteristics data for 'main study cohort' and 'Japan extension cohort' was collected and reported separately.
|
|
Forced Vital Capacity (FVC)
Japan Extension Cohort
|
—
|
—
|
2.5864 liters
STANDARD_DEVIATION 0.5521 • n=18 Participants • Per planned analysis, the Baseline characteristics data for 'main study cohort' and 'Japan extension cohort' was collected and reported separately.
|
2.5486 liters
STANDARD_DEVIATION 0.5153 • n=19 Participants • Per planned analysis, the Baseline characteristics data for 'main study cohort' and 'Japan extension cohort' was collected and reported separately.
|
2.5670 liters
STANDARD_DEVIATION 0.5264 • n=37 Participants • Per planned analysis, the Baseline characteristics data for 'main study cohort' and 'Japan extension cohort' was collected and reported separately.
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were calculated using mixed model for repeated measures (MMRM).
Outcome measures
| Measure |
DB Period (Main Study Cohort) - Pamrevlumab
n=163 Participants
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Main Study Cohort) - Placebo
n=149 Participants
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
|---|---|---|---|---|
|
DB Period (Main Study Cohort): Change From Baseline in FVC at Week 48
|
-0.26 liters
Standard Error 0.046
|
-0.33 liters
Standard Error 0.050
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that could forcibly be blown out after full inspiration in the upright position, measured in liters.
Outcome measures
| Measure |
DB Period (Main Study Cohort) - Pamrevlumab
n=15 Participants
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Main Study Cohort) - Placebo
n=15 Participants
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
|---|---|---|---|---|
|
DB Period (Japan Extension Cohort): Change From Baseline in FVC at Week 48
|
-0.0445 liters
Standard Deviation 0.1805
|
-0.1835 liters
Standard Deviation 0.2389
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48Population: ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Time to disease progression was defined as the number of weeks from randomization to either the first occurrence of an absolute ≥10% decline from baseline in percent predicted FVC (FVCpp) or all-cause death, whichever occurred first. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
Outcome measures
| Measure |
DB Period (Main Study Cohort) - Pamrevlumab
n=49 Participants
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Main Study Cohort) - Placebo
n=56 Participants
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
|---|---|---|---|---|
|
DB Period (Main Study Cohort): Time to Disease Progression
|
54.3 weeks
Interval 52.7 to
Due to the low number of participants with an event, the upper limit of 95% confidence interval (CI) could not be calculated.
|
50.7 weeks
Interval 50.3 to 54.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48Population: ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
The components of the clinical composite endpoint included acute IPF exacerbation, respiratory hospitalization, or death. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
Outcome measures
| Measure |
DB Period (Main Study Cohort) - Pamrevlumab
n=40 Participants
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Main Study Cohort) - Placebo
n=45 Participants
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
|---|---|---|---|---|
|
DB Period (Main Study Cohort): Time to First Occurrence of Any Component of the Clinical Composite Endpoint
|
62.7 weeks
Interval 59.0 to
Due to the low number of participants with an event, the upper limit of 95% CI could not be calculated.
|
NA weeks
Interval 57.9 to
Due to the low number of participants with an event, median and upper limit of 95% CI could not be calculated.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 48Population: ITT population included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
The QLF volume was calculated as QLF = total lung capacity volume multiplied by percentage (%) of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE was calculated using MMRM.
Outcome measures
| Measure |
DB Period (Main Study Cohort) - Pamrevlumab
n=157 Participants
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Main Study Cohort) - Placebo
n=143 Participants
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Pamrevlumab
n=15 Participants
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Placebo
n=15 Participants
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
|---|---|---|---|---|
|
DB Period (Main Study Cohort and Japan Extension Cohort): Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
|
251.38 liters
Standard Error 38.010
|
267.96 liters
Standard Error 38.763
|
45.08 liters
Standard Error 88.265
|
78.18 liters
Standard Error 119.300
|
SECONDARY outcome
Timeframe: Up to Week 48Population: ITT population included all randomized participants.
Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
Outcome measures
| Measure |
DB Period (Main Study Cohort) - Pamrevlumab
n=181 Participants
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Main Study Cohort) - Placebo
n=175 Participants
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
|---|---|---|---|---|
|
DB Period (Main Study Cohort): Time to First Acute IPF Exacerbation
|
62.7 weeks
Interval 62.7 to
Due to the low number of participants with an event, the upper limit of 95% CI could not be calculated.
|
NA weeks
Due to the low number of participants with an event, median and 95% CI could not be calculated.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48Population: ITT population included all randomized participants.
Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
Outcome measures
| Measure |
DB Period (Main Study Cohort) - Pamrevlumab
n=181 Participants
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Main Study Cohort) - Placebo
n=175 Participants
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
|---|---|---|---|---|
|
DB Period (Main Study Cohort): Time to All-Cause Mortality
|
NA weeks
Interval 60.6 to
Due to the low number of participants with an event, median and upper limit of 95% CI could not be calculated.
|
NA weeks
Interval 60.1 to
Due to the low number of participants with an event, median and upper limit of 95% CI could not be calculated.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48Population: ITT population included all randomized participants.
Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.
Outcome measures
| Measure |
DB Period (Main Study Cohort) - Pamrevlumab
n=181 Participants
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Main Study Cohort) - Placebo
n=175 Participants
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Pamrevlumab
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Placebo
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
|---|---|---|---|---|
|
DB Period (Main Study Cohort): Time to First Respiratory Hospitalizations
|
62.7 weeks
Interval 59.0 to
Due to the low number of participants with an event, the upper limit of 95% CI could not be calculated.
|
NA weeks
Interval 57.9 to
Due to the low number of participants with an event, median and upper limit of 95% CI could not be calculated.
|
—
|
—
|
Adverse Events
DB Period (Main Study Cohort): Pamrevlumab
Serious events: 51 serious events
Other events: 129 other events
Deaths: 23 deaths
DB Period (Main Study Cohort): Placebo
Serious events: 60 serious events
Other events: 121 other events
Deaths: 22 deaths
DB Period (Japan Extension Cohort)Pamrevlumab
Serious events: 5 serious events
Other events: 17 other events
Deaths: 1 deaths
DB Period (Japan Extension Cohort): Placebo
Serious events: 8 serious events
Other events: 16 other events
Deaths: 2 deaths
OLE Period: Pamrevlumab/Pamrevlumab
Serious events: 42 serious events
Other events: 76 other events
Deaths: 17 deaths
OLE Period: Placebo/Pamrevlumab
Serious events: 33 serious events
Other events: 75 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
DB Period (Main Study Cohort): Pamrevlumab
n=181 participants at risk
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the DB period.
|
DB Period (Main Study Cohort): Placebo
n=175 participants at risk
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period.
|
DB Period (Japan Extension Cohort)Pamrevlumab
n=18 participants at risk
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Placebo
n=19 participants at risk
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
OLE Period: Pamrevlumab/Pamrevlumab
n=129 participants at risk
Participants who received pamrevlumab in the DB period continued to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
|
OLE Period: Placebo/Pamrevlumab
n=123 participants at risk
Participants who received placebo matched to pamrevlumab in the DB period, received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
4.4%
8/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.6%
8/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.9%
5/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.3%
4/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
COVID-19
|
1.7%
3/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Chemical peritonitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
7.7%
14/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.3%
18/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
11.1%
2/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
15.8%
3/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
12.4%
16/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
11.4%
14/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Cardiac perforation
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Cardiac tamponade
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Left ventricular failure
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Right ventricular failure
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.7%
3/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.3%
4/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Faecaloma
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Asthenia
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Death
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Peripheral swelling
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Inflammation
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Cystitis
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Epiglottitis
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Septic shock
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.9%
5/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Lyme carditis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Gangrene
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Vaccine breakthrough infection
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Cerebellar stroke
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Syncope
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Psychiatric disorders
Delirium
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
3/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.2%
4/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.7%
3/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.3%
3/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.2%
4/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.1%
5/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic cyst
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Vascular disorders
Hypertension
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Vascular disorders
Varicose vein
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Vascular disorders
Shock
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
Other adverse events
| Measure |
DB Period (Main Study Cohort): Pamrevlumab
n=181 participants at risk
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the DB period.
|
DB Period (Main Study Cohort): Placebo
n=175 participants at risk
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period.
|
DB Period (Japan Extension Cohort)Pamrevlumab
n=18 participants at risk
Participants received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
|
DB Period (Japan Extension Cohort): Placebo
n=19 participants at risk
Participants received placebo matched to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
|
OLE Period: Pamrevlumab/Pamrevlumab
n=129 participants at risk
Participants who received pamrevlumab in the DB period continued to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
|
OLE Period: Placebo/Pamrevlumab
n=123 participants at risk
Participants who received placebo matched to pamrevlumab in the DB period, received pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab was commercially available for the indication of IPF, or the sponsor decided to end the OLE period, whichever occurred first.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
3/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.5%
2/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.3%
3/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Eye disorders
Cataract
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.3%
3/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Eye disorders
Scleritis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
5/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.5%
2/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.4%
3/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
10/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
6.3%
11/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
22.2%
4/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
21.1%
4/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
6.2%
8/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.1%
5/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.4%
3/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
4/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.0%
7/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
7/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.6%
8/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.9%
5/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Oesophageal polyp
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
11.1%
2/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.9%
5/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.5%
2/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Chest pain
|
1.7%
3/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.3%
4/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Fatigue
|
6.6%
12/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.7%
10/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
6.2%
8/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.4%
3/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Feeling abnormal
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Infusion site erythema
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
11.1%
2/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Malaise
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Oedema peripheral
|
1.7%
3/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.3%
3/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
General disorders
Pyrexia
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.0%
7/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.5%
2/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.1%
5/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Bronchitis
|
7.7%
14/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
8.0%
14/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
11.6%
15/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
7.3%
9/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
COVID-19
|
12.2%
22/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
9.1%
16/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
27.8%
5/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.5%
2/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.9%
14/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
8.9%
11/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Cytomegalovirus enterocolitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Herpes zoster
|
1.7%
3/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
10/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.4%
6/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
15.8%
3/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.7%
6/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.4%
3/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Pneumonia
|
3.3%
6/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.0%
7/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.1%
4/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.4%
3/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Sinusitis
|
2.2%
4/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.9%
5/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.1%
5/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Tinea pedis
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
11/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.9%
5/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.1%
4/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.1%
5/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
3/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.7%
3/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.9%
5/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.9%
6/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Chemical peritonitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
4/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Investigations
Blood pressure decreased
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Investigations
C-reactive protein increased
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.7%
3/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Investigations
SARS-CoV-2 test positive
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Investigations
Weight decreased
|
3.3%
6/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
6.3%
11/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.5%
2/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.3%
3/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.3%
6/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.9%
5/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.4%
3/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.5%
2/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
9/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.7%
3/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.1%
4/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.3%
4/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.7%
3/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.5%
2/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
6/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.6%
8/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.3%
4/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
3/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.7%
3/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.3%
3/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Amnesia
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Dizziness
|
5.5%
10/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
4.0%
7/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Headache
|
7.2%
13/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
6.9%
12/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.3%
3/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
3.3%
4/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Olfactory dysfunction
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Psychiatric disorders
Depression
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Psychiatric disorders
Insomnia
|
2.8%
5/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.55%
1/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.4%
37/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
14.3%
25/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
16.7%
3/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.5%
2/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
8.5%
11/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
11.4%
14/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.9%
18/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
9.1%
16/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
7.0%
9/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
6.5%
8/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
10.5%
19/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
9.7%
17/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
36.8%
7/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.4%
7/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.7%
7/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
11.1%
2/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.1%
2/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
10.5%
2/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.7%
3/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.7%
3/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
11.1%
2/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.6%
2/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.1%
2/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
1.7%
3/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.57%
1/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.6%
1/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.81%
1/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
5.3%
1/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
|
Vascular disorders
Hypertension
|
6.1%
11/181 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.9%
5/175 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/18 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.00%
0/19 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
0.78%
1/129 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
2.4%
3/123 • From first dose of study drug until 60 days after last dose of study drug (maximum exposure: 51.1 weeks [in main study cohort DB period], 49.1 weeks [in Japan extension cohort DB period], and 153.1 weeks [in OLE period]
The safety analysis set included all participants who received any study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The multisite consortium can publish any time after the data is collected and analyzed by FibroGen. The investigator can only publish after the multisite consortium publishes (or tries to publish and fails). FibroGen has 60 days to review a publication and can extend the embargo up to an additional 120 days (or 180 total).
- Publication restrictions are in place
Restriction type: OTHER