Trial Outcomes & Findings for Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (NCT NCT03053063)
NCT ID: NCT03053063
Last Updated: 2020-05-07
Results Overview
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
883 participants
Primary outcome timeframe
Week 48
Results posted on
2020-05-07
Participant Flow
Participants were enrolled at study sites in North America, Asia, Australia, New Zealand, Europe and Puerto Rico. The first participant was screened on 30 January 2017. The last study visit occurred on 06 May 2019.
2154 participants were screened.
Participant milestones
| Measure |
SEL 18 mg
Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo for up to 240 weeks.
|
SEL 6 mg
Randomized Phase: SEL 6 mg tablet orally once daily + placebo for up to 240 weeks.
|
Placebo
Randomized Phase: Placebo to match SEL 18 mg and 6 mg tablets orally once daily for up to 240 weeks.
|
Open-Label SEL 18 mg
Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks, including the treatment duration in the randomized phase.
|
|---|---|---|---|---|
|
Randomized Phase
STARTED
|
355
|
354
|
174
|
0
|
|
Randomized Phase
COMPLETED
|
0
|
0
|
0
|
0
|
|
Randomized Phase
NOT COMPLETED
|
355
|
354
|
174
|
0
|
|
Open-Label Phase
STARTED
|
0
|
0
|
0
|
23
|
|
Open-Label Phase
COMPLETED
|
0
|
0
|
0
|
0
|
|
Open-Label Phase
NOT COMPLETED
|
0
|
0
|
0
|
23
|
Reasons for withdrawal
| Measure |
SEL 18 mg
Randomized Phase: Selonsertib (SEL) 18 mg tablet orally once daily + placebo for up to 240 weeks.
|
SEL 6 mg
Randomized Phase: SEL 6 mg tablet orally once daily + placebo for up to 240 weeks.
|
Placebo
Randomized Phase: Placebo to match SEL 18 mg and 6 mg tablets orally once daily for up to 240 weeks.
|
Open-Label SEL 18 mg
Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks, including the treatment duration in the randomized phase.
|
|---|---|---|---|---|
|
Randomized Phase
Study Terminated by Sponsor
|
326
|
317
|
161
|
0
|
|
Randomized Phase
Withdrew consent
|
8
|
11
|
5
|
0
|
|
Randomized Phase
Investigator's Discretion
|
8
|
6
|
2
|
0
|
|
Randomized Phase
Lost to Follow-up
|
3
|
5
|
1
|
0
|
|
Randomized Phase
Adverse Event
|
0
|
1
|
0
|
0
|
|
Randomized Phase
Randomized but Never Treated
|
1
|
3
|
2
|
0
|
|
Randomized Phase
Entered the Open-Label Phase
|
9
|
11
|
3
|
0
|
|
Open-Label Phase
Study Terminated by Sponsor
|
0
|
0
|
0
|
19
|
|
Open-Label Phase
Death
|
0
|
0
|
0
|
2
|
|
Open-Label Phase
Investigator's discretion
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
SEL 18 mg
n=354 Participants
Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks.
Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
SEL 6 mg
n=351 Participants
Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks.
Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
Placebo
n=172 Participants
Randomized Phase: Placebo tablet orally once daily for up to 240 weeks.
Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
Total
n=877 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race/Ethnicity, Customized
Race · White
|
261 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
676 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
57 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
60 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
58 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
547 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
330 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
73 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
300 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
746 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.
Outcome measures
| Measure |
SEL 18 mg
n=354 Participants
Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks.
Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
SEL 6 mg
n=351 Participants
Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks.
Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
Placebo
n=172 Participants
Randomized Phase: Placebo tablet orally once daily for up to 240 weeks.
Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH
|
14.4 percentage of participants
Interval 10.9 to 18.5
|
12.8 percentage of participants
Interval 9.5 to 16.8
|
12.8 percentage of participants
Interval 8.2 to 18.7
|
PRIMARY outcome
Timeframe: Week 240Population: No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.
EFS was assessed by the time to the first clinical event, including liver decompensation events, liver transplantation and all-cause mortality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 240Population: No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the NAS criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).
Outcome measures
| Measure |
SEL 18 mg
n=354 Participants
Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks.
Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
SEL 6 mg
n=351 Participants
Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks.
Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
Placebo
n=172 Participants
Randomized Phase: Placebo tablet orally once daily for up to 240 weeks.
Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48
|
18.9 percentage of participants
Interval 15.0 to 23.4
|
16.8 percentage of participants
Interval 13.0 to 21.1
|
15.7 percentage of participants
Interval 10.6 to 22.0
|
SECONDARY outcome
Timeframe: Week 240Population: No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 48Population: Participants in the Full Analysis Set were analyzed.
NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning reduced to 0 from a value ≥ 1 at baseline; both criteria were necessary conditions. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1.
Outcome measures
| Measure |
SEL 18 mg
n=353 Participants
Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks.
Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
SEL 6 mg
n=351 Participants
Randomized Phase : Selonsertib (SEL) 6 mg tablet orally once daily + placebo for up to 240 weeks.
Open-label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an open-label phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
Placebo
n=172 Participants
Randomized Phase: Placebo tablet orally once daily for up to 240 weeks.
Open-label Phase: Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Had NASH Resolution at Week 48
|
2.3 percentage of participants
Interval 1.0 to 4.4
|
3.7 percentage of participants
Interval 2.0 to 6.3
|
4.1 percentage of participants
Interval 1.7 to 8.2
|
SECONDARY outcome
Timeframe: Week 240Population: No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint.
NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning reduced to 0 from a value ≥ 1 at baseline; both criteria were necessary conditions.As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1.
Outcome measures
Outcome data not reported
Adverse Events
SEL 18 mg
Serious events: 60 serious events
Other events: 251 other events
Deaths: 0 deaths
SEL 6 mg
Serious events: 53 serious events
Other events: 276 other events
Deaths: 0 deaths
Placebo
Serious events: 22 serious events
Other events: 135 other events
Deaths: 0 deaths
Open-Label SEL 18 mg
Serious events: 7 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
SEL 18 mg
n=354 participants at risk
Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks.
|
SEL 6 mg
n=351 participants at risk
Randomized Phase: SEL 6 mg tablet orally once daily + placebo for up to 240 weeks.
|
Placebo
n=172 participants at risk
Randomized Phase: Placebo tablet orally once daily for up to 240 weeks.
|
Open-Label SEL 18 mg
n=23 participants at risk
Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Enterocolitis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal wall thickening
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.57%
2/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.57%
2/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Bipolar disorder
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Hydrosalpinx
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hepatic hydrothorax
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Shock haemorrhagic
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.85%
3/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Model for end stage liver disease score increased
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.57%
2/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Obesity
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.57%
2/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.7%
2/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.57%
2/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Duodenitis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
4/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.57%
2/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Appendiceal mucocoele
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.85%
3/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.85%
3/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.85%
3/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mesenteric panniculitis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Visceral venous thrombosis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.85%
3/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
2/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.57%
2/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.7%
3/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.85%
3/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Haemobilia
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Intrahepatic portal hepatic venous fistula
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.85%
3/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.85%
3/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Enterocolitis infectious
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
2/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Genital herpes
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasal abscess
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Perineal abscess
|
0.28%
1/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
SEL 18 mg
n=354 participants at risk
Randomized Phase: SEL 18 mg tablet orally once daily + placebo for up to 240 weeks.
|
SEL 6 mg
n=351 participants at risk
Randomized Phase: SEL 6 mg tablet orally once daily + placebo for up to 240 weeks.
|
Placebo
n=172 participants at risk
Randomized Phase: Placebo tablet orally once daily for up to 240 weeks.
|
Open-Label SEL 18 mg
n=23 participants at risk
Participants who experienced a hepatic clinical event during the randomized phase, prior to completing the Week 240 visit, were offered the option to roll over into an OL phase to receive OL SEL 18 mg daily for a total treatment duration, including the treatment duration in the randomized phase, of 240 weeks.
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
6.2%
22/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.6%
23/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.9%
17/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
13.3%
47/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.7%
48/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.2%
21/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.4%
4/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.0%
7/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.4%
5/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
2/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.4%
4/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
6.8%
24/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
28/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.1%
7/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.7%
2/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.6%
27/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.4%
33/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.1%
14/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
7/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.3%
8/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
1.2%
2/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.7%
2/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.2%
29/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.7%
27/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.4%
11/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.7%
2/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
19/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
3.7%
13/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.8%
10/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
22/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.3%
22/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.0%
12/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.0%
3/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.6%
34/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.4%
33/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.0%
19/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.7%
2/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.9%
42/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.5%
37/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
12.2%
21/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.0%
3/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
13.0%
46/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.4%
47/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
10.5%
18/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.4%
51/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
17.1%
60/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
23.3%
40/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.7%
2/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
47/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.8%
59/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.9%
17/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.7%
2/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
24/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
28/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.1%
7/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.0%
3/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
11.9%
42/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.5%
51/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.6%
20/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
5.6%
20/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.6%
23/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.8%
10/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
4.5%
16/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.7%
27/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.8%
10/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
7.6%
27/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.8%
24/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.7%
8/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
42/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.4%
33/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
16.3%
28/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
7.1%
25/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.7%
27/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.4%
11/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.1%
43/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
14.8%
52/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.7%
15/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
9.3%
33/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
11.1%
39/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.4%
11/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.6%
20/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
6.6%
23/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.0%
12/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.56%
2/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.28%
1/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.58%
1/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.0%
3/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.4%
19/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.0%
28/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.7%
15/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.0%
3/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.6%
34/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
8.5%
30/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
9.3%
16/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
14/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
7.1%
25/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.8%
10/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
13.0%
3/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.2%
15/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.4%
19/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.2%
9/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
0.00%
0/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
16/354 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
5.4%
19/351 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
2.9%
5/172 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
4.3%
1/23 • First dose date up to last dose (maximum: 108.7 weeks) plus 30 days
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER