Trial Outcomes & Findings for REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy (NCT NCT00087646)
NCT ID: NCT00087646
Last Updated: 2016-01-14
Results Overview
Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA \< 50 International Units Per Millilitre (IU/mL) measured \>= 20 weeks after treatment end, ie, \>=140 days after treatment end.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
948 participants
Primary outcome timeframe
Up to 72 weeks (Group A) and 48 weeks (Group D)
Results posted on
2016-01-14
Participant Flow
The study was conducted from 16 September 2003 to 27 February 2007. Participants were recruited over a total of 106 centers \[(United States (37), Germany (19), Spain (10), France (9), Italy (7), Greece (5), Turkey (4), Belgium (3), Canada (3), Portugal (3), Sweden (3), Brazil (1), Switzerland (1), and UK (1)\] in the study.
A total of 950 participants were randomized (318, 158, 158, and 316 in groups A, B, C, and D, respectively), 942 received the study medication. A total of 8 randomized participants did not receive study drug for various reasons which includes withdrew consent (5), violated the study entry criteria (1), and two had other protocol violations.
Participant milestones
| Measure |
Group A
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group B
Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
|
Group C
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
317
|
156
|
156
|
313
|
|
Overall Study
COMPLETED
|
182
|
114
|
91
|
229
|
|
Overall Study
NOT COMPLETED
|
135
|
42
|
65
|
84
|
Reasons for withdrawal
| Measure |
Group A
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group B
Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
|
Group C
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
37
|
6
|
18
|
20
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
2
|
2
|
|
Overall Study
Insufficient therapeutic response
|
64
|
24
|
38
|
51
|
|
Overall Study
Refused Treatment/Did Not Cooperate
|
13
|
6
|
4
|
5
|
|
Overall Study
Failure to Return
|
5
|
2
|
2
|
3
|
|
Overall Study
Administrative/Other
|
6
|
1
|
1
|
2
|
|
Overall Study
Other Protocol Violation
|
3
|
1
|
0
|
0
|
|
Overall Study
Violation of Selection Criteria at Entry
|
1
|
0
|
0
|
1
|
Baseline Characteristics
REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy
Baseline characteristics by cohort
| Measure |
Group A
n=317 Participants
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group B
n=156 Participants
Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
|
Group C
n=156 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
n=313 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
Total
n=942 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 8.73 • n=99 Participants
|
48.8 years
STANDARD_DEVIATION 9.93 • n=107 Participants
|
49.4 years
STANDARD_DEVIATION 8.46 • n=206 Participants
|
48.5 years
STANDARD_DEVIATION 8.97 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 8.97 • n=31 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
101 Participants
n=7 Participants
|
326 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
212 Participants
n=7 Participants
|
616 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 72 weeks (Group A) and 48 weeks (Group D)Population: Intent-to-treat analysis population (ITT) included, all participants randomized who received at least one dose of study medication.
Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA \< 50 International Units Per Millilitre (IU/mL) measured \>= 20 weeks after treatment end, ie, \>=140 days after treatment end.
Outcome measures
| Measure |
Group A
n=317 Participants
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group D
n=313 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
Group C
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Sustained Virological Response Rate
|
52 participants
|
27 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 48 and Week 72Population: ITT population included all participants randomized who received at least one dose of study medication.
SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA \< 50 International Units Per Millilitre (IU/mL) measured \>= 20 weeks after treatment end, ie, \>=140 days after treatment end.
Outcome measures
| Measure |
Group A
n=473 Participants
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group D
n=469 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
Group C
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)
|
63 participants
|
49 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 48 and Week 72Population: ITT population included all participants randomized who received at least one dose of study medication.
SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA \< 50 International Units Per Millilitre (IU/mL) measured \>= 20 weeks after treatment end, ie, \>=140 days after treatment end.
Outcome measures
| Measure |
Group A
n=473 Participants
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group D
n=469 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
Group C
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)
|
74 participants
|
38 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 12, 24, 48 and EOTPopulation: ITT population included all participants randomized who received at least one dose of study medication.
The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA \< 50 IU/mL measured \>= 20 weeks after treatment end, ie, \>=140 days after treatment end) are reported. End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (\<50 IU/mL) at study day of last dose of study medication (+/- 28 days).
Outcome measures
| Measure |
Group A
n=317 Participants
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group D
n=313 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
Group C
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Undetectable HCV-RNA
At Week 12
|
24 percentage of participants
|
11 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Undetectable HCV-RNA
At Week 24
|
32 percentage of participants
|
27 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Undetectable HCV-RNA
At Week 48
|
32 percentage of participants
|
26 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Undetectable HCV-RNA
At EOT
|
31 percentage of participants
|
28 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 12 and 24Population: ITT population included all the participants randomized who received at least one dose of study medication.
Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.
Outcome measures
| Measure |
Group A
n=317 Participants
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group D
n=313 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
Group C
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With >=2log Drop in HCV-RNA
Week 12
|
62 percentage of participants
|
42 percentage of participants
|
—
|
—
|
|
Percentage of Participants With >=2log Drop in HCV-RNA
Week 24
|
51 percentage of participants
|
47 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 12 and 24Population: ITT population included all participants randomized who received at least one dose of study medication.
The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (\<50 IU/ML) and not quantifiable (\<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.
Outcome measures
| Measure |
Group A
n=473 Participants
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group D
n=469 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
Group C
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)
HCV RNA Change from BL to Week 12 (n= 424, 421)
|
-2.75 IU/ML
Interval -2.89 to -2.61
|
-2.18 IU/ML
Interval -2.32 to -2.03
|
—
|
—
|
|
Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)
HCV RNA Change from BL to Week 24 (n= 390, 399)
|
-2.88 IU/ML
Interval -3.05 to -2.7
|
-2.64 IU/ML
Interval -2.81 to -2.47
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 96 (Group A and C) and Week 72 (Group B and D)Population: ITT population included all participants randomized who received at least one dose of study medication.
Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.
Outcome measures
| Measure |
Group A
n=317 Participants
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group D
n=156 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
Group C
n=156 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
n=313 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response
|
51 percentage of participants
|
22 percentage of participants
|
41 percentage of participants
|
33 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96 (Group A and C) and Week 72 (Group B and D)Population: ITT population included all participants randomized who received at least one dose of study medication.
The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.
Outcome measures
| Measure |
Group A
n=317 Participants
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group D
n=156 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
Group C
n=156 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
n=313 Participants
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Relapse After End of Treatment
|
49 percentage of participants
|
78 percentage of participants
|
59 percentage of participants
|
67 percentage of participants
|
Adverse Events
Group A
Serious events: 33 serious events
Other events: 306 other events
Deaths: 0 deaths
Group B
Serious events: 14 serious events
Other events: 151 other events
Deaths: 0 deaths
Group C
Serious events: 28 serious events
Other events: 150 other events
Deaths: 0 deaths
Group D
Serious events: 33 serious events
Other events: 298 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=317 participants at risk
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group B
n=156 participants at risk
Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
|
Group C
n=156 participants at risk
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
n=313 participants at risk
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
1.3%
4/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.3%
2/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Cellulitis
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.3%
4/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Tooth abscess
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Appendicitis
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Ear infection
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Enterococcal sepsis
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Infected insect bite
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Infective spondylitis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Influenza
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Otitis media
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Viral infection
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.63%
2/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.3%
2/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.6%
5/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.95%
3/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Oesophageal varices Haemorrhage
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Enteritis
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Gastritis
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Nausea
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Vomiting
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.3%
2/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
2/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphatic system neoplasm
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Unspecified Tonsil cancer
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Depression
|
0.63%
2/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.3%
2/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Aggression
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Vision blurred
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Retinal artery embolism
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Retinal exudates
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Insulin-dependent Dehydration
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Chest pain
|
0.63%
2/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Influenza like illness
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Pyrexia
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Convulsion
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Facial palsy
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Grand mal convulsion
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Angina unstable
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Ear and labyrinth disorders
Vertigo
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Deep vein thrombosis
|
0.32%
1/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.64%
1/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.32%
1/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
Other adverse events
| Measure |
Group A
n=317 participants at risk
Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
|
Group B
n=156 participants at risk
Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
|
Group C
n=156 participants at risk
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
|
Group D
n=313 participants at risk
Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.1%
13/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.2%
5/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.2%
10/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.1%
48/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
20.5%
32/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
17.3%
27/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
9.9%
31/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.4%
33/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
10.9%
17/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
8.3%
13/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.0%
22/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.6%
62/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
16.7%
26/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
21.2%
33/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
20.4%
64/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.4%
33/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.2%
19/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.2%
19/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
14.1%
44/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.6%
24/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.8%
9/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
6/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
4.8%
15/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Fatigue
|
42.3%
134/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
39.7%
62/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
36.5%
57/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
43.8%
137/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Asthenia
|
27.8%
88/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
27.6%
43/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
31.4%
49/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
28.4%
89/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Pyrexia
|
25.6%
81/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
28.2%
44/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
21.2%
33/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
23.6%
74/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Influenza like illness
|
27.4%
87/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
25.0%
39/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
23.7%
37/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
25.6%
80/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Irritability
|
17.0%
54/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
20.5%
32/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
17.3%
27/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
17.3%
54/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Chills
|
14.8%
47/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
18.6%
29/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.2%
19/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.1%
38/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Pain
|
6.9%
22/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
10/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.7%
12/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
20/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Injection site erythema
|
6.6%
21/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
10/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
4.5%
14/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Nausea
|
28.7%
91/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
32.1%
50/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
26.3%
41/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
24.9%
78/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.8%
66/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
19.9%
31/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
17.3%
27/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
14.1%
44/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
34/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
9.0%
14/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
8.3%
13/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
8.9%
28/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.5%
30/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.1%
11/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
10/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
10.2%
32/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
16/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.8%
9/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
10/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.1%
19/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
18/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.1%
11/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
4.8%
15/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Dry mouth
|
6.3%
20/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
9.6%
15/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
6/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
12/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
12/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
6/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
6/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.4%
17/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.1%
70/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
29.5%
46/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
25.0%
39/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
25.6%
80/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.0%
76/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
18.6%
29/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
19.9%
31/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
18.2%
57/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
31/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
11.5%
18/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.5%
39/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.6%
24/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.2%
5/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
20/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.7%
15/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.8%
9/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.5%
11/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
7/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
4.5%
7/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.6%
4/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
16/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.8%
85/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
24.4%
38/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
25.0%
39/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
26.5%
83/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
53/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
19.9%
31/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
17.3%
27/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
13.7%
43/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.0%
38/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
15.4%
24/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
17.3%
27/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.1%
38/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.7%
37/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
15.4%
24/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
9.0%
14/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
13.7%
43/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Headache
|
36.9%
117/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
43.6%
68/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
35.9%
56/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
39.3%
123/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Dizziness
|
10.1%
32/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
9.6%
15/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
10.9%
17/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
9.3%
29/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Disturbance in attention
|
4.4%
14/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
10/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.4%
17/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Tremor
|
2.8%
9/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.9%
3/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.6%
8/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Insomnia
|
31.2%
99/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
29.5%
46/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
30.1%
47/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
28.4%
89/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Depression
|
17.7%
56/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.8%
20/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
18.6%
29/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
18.5%
58/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Anxiety
|
6.6%
21/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.2%
5/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.7%
12/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.3%
23/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Sleep disorder
|
4.4%
14/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.8%
9/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
4.5%
7/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
4.2%
13/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.3%
20/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.1%
11/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
6/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.6%
8/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
22.1%
70/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
16.0%
25/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
17.9%
28/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
19.5%
61/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.7%
18/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.2%
5/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.3%
2/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
16/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Sinusitis
|
5.4%
17/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
6/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.2%
5/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
12/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Bronchitis
|
5.4%
17/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
4.5%
7/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.6%
8/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Upper respiratory tract Infection
|
4.7%
15/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.1%
11/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.6%
5/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
12/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.1%
11/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.9%
3/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.5%
11/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Weight decreased
|
9.8%
31/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
6/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
9.6%
15/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.4%
17/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Hypertension
|
6.6%
21/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.1%
11/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
12/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Vision blurred
|
4.7%
15/317 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.1%
8/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
6/156 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
4.5%
14/313 • Up to Week 96 (Groups A and C) and 72-week (Groups B and D)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER