Trial Outcomes & Findings for Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus (NCT NCT01408576)

Last Updated: 2018-10-03

Results Overview

A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1250 participants

Primary outcome timeframe

During the treatment period (through Week 96)

Results posted on

2018-10-03

Participant Flow

The study started to enroll patients in July 2011 and concluded in February 2016.

Participant Flow refers to the Enrolled Set, that consisted of all subjects who gave informed consent.

Participant milestones

Participant milestones
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Overall Study STARTED	244	498	508
Overall Study COMPLETED	56	0	0
Overall Study NOT COMPLETED	188	498	508

Reasons for withdrawal

Reasons for withdrawal
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Overall Study Lack of Efficacy	17	30	48
Overall Study Protocol Violation	1	2	2
Overall Study Lost to Follow-up	10	9	17
Overall Study Withdrawal by Subject	34	60	66
Overall Study Sponsor terminated study	89	333	330
Overall Study AE, serious fatal	4	4	1
Overall Study SAE, non-fatal	11	23	14
Overall Study AE, non-serious non-fatal	12	19	11
Overall Study SAE, non-fatal+AE, non-serious non-fatal	0	1	1
Overall Study AE, unknown type	0	1	0
Overall Study Other	10	16	18

Baseline Characteristics

Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) n=244 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) n=498 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) n=508 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Total Title n=1250 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	239 Participants n=5 Participants	489 Participants n=7 Participants	490 Participants n=5 Participants	1218 Participants n=4 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants	32 Participants n=4 Participants
Age, Continuous	41.0 years STANDARD_DEVIATION 12.0 • n=5 Participants	41.9 years STANDARD_DEVIATION 11.5 • n=7 Participants	42.5 years STANDARD_DEVIATION 11.9 • n=5 Participants	42.0 years STANDARD_DEVIATION 11.7 • n=4 Participants
Sex: Female, Male Female	226 Participants n=5 Participants	467 Participants n=7 Participants	478 Participants n=5 Participants	1171 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	31 Participants n=7 Participants	30 Participants n=5 Participants	79 Participants n=4 Participants

PRIMARY outcome

Timeframe: During the treatment period (through Week 96)

Population: Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received more than (\>) 0mL of study medication.

Outcome measures

Outcome measures
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) n=244 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) n=497 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) n=507 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Epratuzumab 600 mg Per Week n=751 Participants 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Subjects n=1248 Participants Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)	26 Participants	45 Participants	25 Participants	51 Participants	96 Participants

PRIMARY outcome

Timeframe: During the treatment period (through Week 96)

Outcome measures

Outcome measures
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) n=244 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) n=497 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) n=507 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Epratuzumab 600 mg Per Week n=751 Participants 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Subjects n=1248 Participants Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)	10.7 percentage of participants	9.1 percentage of participants	4.9 percentage of participants	6.8 percentage of participants	7.7 percentage of participants

PRIMARY outcome

Timeframe: During the treatment period (through Week 96)

A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes: * Death * Life-threatening * Significant or persistent disability/incapacity * Congenital anomaly/birth defect (including that occurring in a fetus) * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious * Initial inpatient hospitalization or prolongation of hospitalization

Outcome measures

Outcome measures
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) n=244 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) n=497 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) n=507 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Epratuzumab 600 mg Per Week n=751 Participants 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Subjects n=1248 Participants Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)	81 Participants	119 Participants	104 Participants	185 Participants	304 Participants

PRIMARY outcome

Timeframe: During the treatment period (through Week 96)

Outcome measures

Outcome measures
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) n=244 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) n=497 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) n=507 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Epratuzumab 600 mg Per Week n=751 Participants 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Subjects n=1248 Participants Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)	33.2 percentage of participants	23.9 percentage of participants	20.5 percentage of participants	24.6 percentage of participants	24.4 percentage of participants

SECONDARY outcome

Timeframe: At Week 48

Population: The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012.

Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.

Outcome measures

Outcome measures
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) n=230 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) n=488 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) n=494 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Epratuzumab 600 mg Per Week n=724 Participants 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Subjects n=1212 Participants Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index	82 Participants	146 Participants	134 Participants	216 Participants	362 Participants

SECONDARY outcome

Timeframe: Week 48

Outcome measures

Outcome measures
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) n=230 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) n=488 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) n=494 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Epratuzumab 600 mg Per Week n=724 Participants 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Subjects n=1212 Participants Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index	35.7 percentage of participants	29.9 percentage of participants	27.1 percentage of participants	29.8 percentage of participants	29.9 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Outcome measures

Outcome measures
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) n=186 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) n=306 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) n=298 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Epratuzumab 600 mg Per Week n=484 Participants 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Subjects n=790 Participants Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index	74 Participants	66 Participants	78 Participants	152 Participants	218 Participants

SECONDARY outcome

Timeframe: Week 96

Outcome measures

Outcome measures
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week (ES) n=186 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W (ES) n=306 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week (ES) n=298 Participants Enrolled Set (ES) of subjects enrolled prior to the approval of Protocol Amendment 2 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Epratuzumab 600 mg Per Week n=484 Participants 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Subjects n=790 Participants Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index	39.8 percentage of participants	21.6 percentage of participants	26.2 percentage of participants	31.4 percentage of participants	27.6 percentage of participants

Adverse Events

Enrollment Cohort 1 Epratuzumab 600 mg Per Week

Serious events: 81 serious events

Other events: 177 other events

Deaths: 4 deaths

Enrollment Cohort 2 Epratuzumab 1200 mg Q2W

Serious events: 119 serious events

Other events: 296 other events

Deaths: 4 deaths

Enrollment Cohort 2 Epratuzumab 600 mg Per Week

Serious events: 104 serious events

Other events: 306 other events

Deaths: 1 deaths

All Epratuzumab 600 mg Per Week

Serious events: 185 serious events

Other events: 483 other events

Deaths: 5 deaths

All Subjects

Serious events: 304 serious events

Other events: 779 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week n=244 participants at risk Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W n=497 participants at risk Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week n=507 participants at risk Subjects enrolled after approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Epratuzumab 600 mg Per Week n=751 participants at risk 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Subjects n=1248 participants at risk Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Nervous system disorders Cerebral infarction	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Cerebrospinal fluid leakage	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Oedematous pancreatitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Oesophageal disorder	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Oesophageal motility disorder	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Hiatus hernia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Inflammatory bowel disease	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Intestinal obstruction	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Oesophageal spasm	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Cerebrovascular disorder	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Epilepsy	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Haemorrhage intracranial	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Peptic ulcer	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Peritoneal haemorrhage	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Salivary gland calculus	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
General disorders Chest pain	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.80% 4/497 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.6% 8/507 • Number of events 9 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.2% 9/751 • Number of events 10 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.0% 13/1248 • Number of events 14 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
General disorders Non-cardiac chest pain	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
General disorders Pyrexia	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
General disorders Asthenia	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
General disorders Drug interaction	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
General disorders Drug intolerance	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
General disorders Hyperthermia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Subileus	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Eosinophilic colitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Gastritis haemorrhagic	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Colitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Colitis ischaemic	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Constipation	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Cerebral haemorrhage	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Crohn's disease	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Blood and lymphatic system disorders Anaemia	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Blood and lymphatic system disorders Leukopenia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Blood and lymphatic system disorders Neutropenia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Blood and lymphatic system disorders Eosinophilia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Blood and lymphatic system disorders Haemorrhagic diathesis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Blood and lymphatic system disorders Pancytopenia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Blood and lymphatic system disorders Splenic cyst	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Myocardial infarction	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Pericarditis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Acute myocardial infarction	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Angina pectoris	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Atrioventricular block complete	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Bradycardia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Cardiac failure congestive	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Pleuropericarditis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Sinoatrial block	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Supraventricular tachycardia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Tachycardia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Cardiac disorders Cardiac arrest	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Congenital, familial and genetic disorders Factor VII deficiency	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Ear and labyrinth disorders Vertigo	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Endocrine disorders Adrenal insufficiency	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Endocrine disorders Toxic nodular goitre	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Eye disorders Cataract	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Eye disorders Amaurosis fugax	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Eye disorders Necrotising retinitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Eye disorders Panophthalmitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Eye disorders Retinal disorder	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Vomiting	0.41% 1/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.60% 3/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.59% 3/507 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.53% 4/751 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.56% 7/1248 • Number of events 8 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Diarrhoea	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.60% 3/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.59% 3/507 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.48% 6/1248 • Number of events 6 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Abdominal pain	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.60% 3/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 5/1248 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Nausea	0.82% 2/244 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Pancreatitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.60% 3/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Gastritis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Abdominal pain upper	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Dysphagia	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Pancreatitis acute	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Anal fissure	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
General disorders Impaired healing	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
General disorders Local swelling	0.41% 1/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
General disorders Oedema peripheral	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
General disorders Serositis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Hepatobiliary disorders Cholelithiasis	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Hepatobiliary disorders Cholecystitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.59% 3/507 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Hepatobiliary disorders Bile duct stone	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Hepatobiliary disorders Cholangitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Hepatobiliary disorders Cholecystitis acute	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Hepatobiliary disorders Cholelithiasis migration	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Hepatobiliary disorders Hepatic steatosis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Immune system disorders Drug hypersensitivity	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Immune system disorders Anaphylactic reaction	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Pneumonia	2.5% 6/244 • Number of events 6 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.4% 7/497 • Number of events 7 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.8% 9/507 • Number of events 10 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.0% 15/751 • Number of events 16 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.8% 22/1248 • Number of events 23 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Sepsis	1.2% 3/244 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.60% 3/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.79% 4/507 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.93% 7/751 • Number of events 8 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.80% 10/1248 • Number of events 11 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Cellulitis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.80% 4/497 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.59% 3/507 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.53% 4/751 • Number of events 6 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.64% 8/1248 • Number of events 10 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Gastroenteritis	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.60% 3/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.53% 4/751 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.56% 7/1248 • Number of events 7 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Arthritis bacterial	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Diverticulitis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Gastroenteritis salmonella	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Influenza	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Pyelonephritis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Urinary tract infection	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Bronchitis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Clostridium difficile colitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Clostridium difficile infection	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Meningitis viral	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Subcutaneous abscess	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Upper respiratory tract infection	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Abscess	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Abscess limb	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Anal abscess	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Appendicitis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Bronchopneumonia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Cystitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Cytomegalovirus chorioretinitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Cytomegalovirus infection	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Endocarditis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Epstein-Barr virus infection	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Escherichia bacteraemia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Escherichia sepsis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Gangrene	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations H1N1 influenza	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Haematoma infection	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Hepatitis B	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Herpes zoster	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Lobar pneumonia	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Lower respiratory tract infection	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Meningitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Meningitis aseptic	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Meningitis bacterial	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Pelvic inflammatory disease	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Perineal abscess	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Pneumonia bacterial	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Pneumonia legionella	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Pneumonia streptococcal	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Pyelonephritis acute	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Respiratory tract infection	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Salpingitis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Tooth abscess	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Meniscus injury	1.2% 3/244 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Head injury	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Laceration	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Radius fracture	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Accidental overdose	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Concussion	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Contusion	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Delayed recovery from anaesthesia	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Femur fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Hip fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Nail avulsion	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Overdose	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Post procedural complication	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Rib fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Tendon injury	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Investigations Biopsy liver	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Investigations Blood cortisol decreased	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Investigations Electrocardiogram QT prolonged	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Investigations Transaminases increased	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Investigations Troponin increased	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Metabolism and nutrition disorders Dehydration	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	2.9% 7/244 • Number of events 7 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.6% 13/497 • Number of events 15 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.4% 12/507 • Number of events 12 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.5% 19/751 • Number of events 19 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.6% 32/1248 • Number of events 34 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 5/1248 • Number of events 7 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Arthralgia	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.59% 3/507 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Osteonecrosis	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Back pain	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Chondromalacia	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Enthesopathy	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Pain in extremity	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders SLE arthritis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Synovial cyst	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative disorder	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Headache	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.79% 4/507 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.53% 4/751 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.48% 6/1248 • Number of events 7 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Transient ischaemic attack	1.2% 3/244 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.59% 3/507 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.80% 6/751 • Number of events 6 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.48% 6/1248 • Number of events 6 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Cerebrovascular accident	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.59% 3/507 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.53% 4/751 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Migraine	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Syncope	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.60% 3/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Convulsion	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Dizziness	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Hypoaesthesia	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.60% 3/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Dysarthria	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Grand mal convulsion	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Monoparesis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Altered state of consciousness	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Hemiparesis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Ischaemic stroke	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Lumbar radiculopathy	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Lupus encephalitis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Memory impairment	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Motor dysfunction	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Myasthenia gravis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Neuropsychiatric lupus	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Optic neuritis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Polyneuropathy	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Radiculitis brachial	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Radiculopathy	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Seizure anoxic	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Sinus headache	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Thecal sac compression	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Thoracic outlet syndrome	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Transverse sinus thrombosis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders VIIth nerve paralysis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	1.2% 3/244 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.53% 4/751 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Pregnancy, puerperium and perinatal conditions Foetal death	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Pregnancy, puerperium and perinatal conditions Premature delivery	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Psychiatric disorders Depression	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Psychiatric disorders Suicide attempt	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Psychiatric disorders Psychotic disorder	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Psychiatric disorders Suicidal ideation	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Renal and urinary disorders Lupus nephritis	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.60% 3/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.48% 6/1248 • Number of events 6 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Renal and urinary disorders Proteinuria	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Renal and urinary disorders Renal failure acute	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Renal and urinary disorders Nephrolithiasis	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Renal and urinary disorders Glomerulonephritis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Renal and urinary disorders Glomerulonephritis membranoproliferative	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Renal and urinary disorders Kidney fibrosis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Renal and urinary disorders Nephritis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Renal and urinary disorders Renal colic	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Renal and urinary disorders Stress urinary incontinence	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Reproductive system and breast disorders Ovarian cyst	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.32% 4/1248 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Reproductive system and breast disorders Endometriosis	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Reproductive system and breast disorders Cervical dysplasia	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Reproductive system and breast disorders Menorrhagia	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Reproductive system and breast disorders Uterine polyp	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Reproductive system and breast disorders Adenomyosis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Reproductive system and breast disorders Endometrial hyperplasia	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Reproductive system and breast disorders Pelvic pain	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Reproductive system and breast disorders Vaginal prolapse	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.60% 3/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 5/1248 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.82% 2/244 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 3/751 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Laryngeal stenosis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Skin and subcutaneous tissue disorders Skin ulcer	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.27% 2/751 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Skin and subcutaneous tissue disorders Blister	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Skin and subcutaneous tissue disorders Chronic cutaneous lupus erythematosus	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Skin and subcutaneous tissue disorders Systemic lupus erythematosus rash	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Surgical and medical procedures Abortion induced	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Surgical and medical procedures Cholecystectomy	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Surgical and medical procedures Hip arthroplasty	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Surgical and medical procedures Joint arthroplasty	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Surgical and medical procedures Polymedication	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Surgical and medical procedures Shoulder operation	0.41% 1/244 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Vascular disorders Deep vein thrombosis	1.2% 3/244 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.39% 2/507 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.67% 5/751 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 5/1248 • Number of events 5 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Vascular disorders Hypertension	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.60% 3/497 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.24% 3/1248 • Number of events 3 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Vascular disorders Venous thrombosis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.40% 2/497 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.16% 2/1248 • Number of events 2 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Vascular disorders Arterial occlusive disease	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Vascular disorders Hypertensive crisis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Vascular disorders Orthostatic hypotension	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Vascular disorders Temporal arteritis	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/497 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/507 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/751 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Vascular disorders Venous thrombosis limb	0.00% 0/244 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.00% 0/497 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.20% 1/507 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.13% 1/751 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.08% 1/1248 • Number of events 1 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)

Other adverse events

Other adverse events
Measure	Enrollment Cohort 1 Epratuzumab 600 mg Per Week n=244 participants at risk Subjects enrolled prior to the approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	Enrollment Cohort 2 Epratuzumab 1200 mg Q2W n=497 participants at risk Subjects enrolled after approval of Protocol Amendment 2. 1200 mg infusions delivered every other week (Q2W) for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles	Enrollment Cohort 2 Epratuzumab 600 mg Per Week n=507 participants at risk Subjects enrolled after approval of Protocol Amendment 2. 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Epratuzumab 600 mg Per Week n=751 participants at risk 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles	All Subjects n=1248 participants at risk Subjects receiving 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles and subjects receiving 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Gastrointestinal disorders Nausea	16.0% 39/244 • Number of events 80 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	11.9% 59/497 • Number of events 86 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	12.2% 62/507 • Number of events 79 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	13.4% 101/751 • Number of events 159 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	12.8% 160/1248 • Number of events 245 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Diarrhoea	11.1% 27/244 • Number of events 41 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	9.5% 47/497 • Number of events 58 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	6.7% 34/507 • Number of events 47 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	8.1% 61/751 • Number of events 88 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	8.7% 108/1248 • Number of events 146 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Vomiting	9.0% 22/244 • Number of events 45 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	6.4% 32/497 • Number of events 43 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	5.7% 29/507 • Number of events 38 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	6.8% 51/751 • Number of events 83 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	6.7% 83/1248 • Number of events 126 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Gastrointestinal disorders Fatigue	7.0% 17/244 • Number of events 24 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.8% 19/497 • Number of events 22 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.1% 21/507 • Number of events 22 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	5.1% 38/751 • Number of events 46 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.6% 57/1248 • Number of events 68 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Upper respiratory tract infection	27.0% 66/244 • Number of events 140 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	15.3% 76/497 • Number of events 126 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	16.2% 82/507 • Number of events 120 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	19.7% 148/751 • Number of events 260 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	17.9% 224/1248 • Number of events 386 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Urinary tract infection	23.0% 56/244 • Number of events 124 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	12.3% 61/497 • Number of events 88 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	12.2% 62/507 • Number of events 90 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	15.7% 118/751 • Number of events 214 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	14.3% 179/1248 • Number of events 302 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Nasopharyngitis	15.6% 38/244 • Number of events 56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	8.5% 42/497 • Number of events 65 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	8.9% 45/507 • Number of events 67 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	11.1% 83/751 • Number of events 123 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	10.0% 125/1248 • Number of events 188 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Bronchitis	13.9% 34/244 • Number of events 38 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	7.0% 35/497 • Number of events 38 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	6.9% 35/507 • Number of events 41 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	9.2% 69/751 • Number of events 79 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	8.3% 104/1248 • Number of events 117 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Sinusitis	10.2% 25/244 • Number of events 40 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	8.2% 41/497 • Number of events 48 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	7.5% 38/507 • Number of events 48 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	8.4% 63/751 • Number of events 88 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	8.3% 104/1248 • Number of events 136 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Influenza	6.1% 15/244 • Number of events 16 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.4% 22/497 • Number of events 24 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.1% 21/507 • Number of events 23 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.8% 36/751 • Number of events 39 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.6% 58/1248 • Number of events 63 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Gastroenteritis	5.7% 14/244 • Number of events 14 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.8% 19/497 • Number of events 21 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.4% 17/507 • Number of events 23 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.1% 31/751 • Number of events 37 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.0% 50/1248 • Number of events 58 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Infections and infestations Conjunctivitis	5.7% 14/244 • Number of events 16 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.0% 15/497 • Number of events 17 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.6% 8/507 • Number of events 8 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.9% 22/751 • Number of events 24 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.0% 37/1248 • Number of events 41 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Back pain	13.9% 34/244 • Number of events 47 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	6.2% 31/497 • Number of events 32 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	6.3% 32/507 • Number of events 32 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	8.8% 66/751 • Number of events 79 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	7.8% 97/1248 • Number of events 111 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Arthralgia	9.8% 24/244 • Number of events 40 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	7.2% 36/497 • Number of events 44 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	5.9% 30/507 • Number of events 38 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	7.2% 54/751 • Number of events 78 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	7.2% 90/1248 • Number of events 122 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	6.1% 15/244 • Number of events 19 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.6% 18/497 • Number of events 26 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.5% 23/507 • Number of events 30 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	5.1% 38/751 • Number of events 49 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.5% 56/1248 • Number of events 75 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Pain in extremity	6.1% 15/244 • Number of events 21 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.0% 15/497 • Number of events 17 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.7% 19/507 • Number of events 21 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.5% 34/751 • Number of events 42 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.9% 49/1248 • Number of events 59 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Muscle spasms	5.3% 13/244 • Number of events 14 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.6% 18/497 • Number of events 20 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.2% 6/507 • Number of events 7 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.5% 19/751 • Number of events 21 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.0% 37/1248 • Number of events 41 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Musculoskeletal and connective tissue disorders Bursitis	6.1% 15/244 • Number of events 24 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.8% 9/497 • Number of events 11 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.4% 7/507 • Number of events 7 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.9% 22/751 • Number of events 31 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.5% 31/1248 • Number of events 42 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Headache	18.9% 46/244 • Number of events 66 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	13.5% 67/497 • Number of events 84 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	11.2% 57/507 • Number of events 80 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	13.7% 103/751 • Number of events 146 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	13.6% 170/1248 • Number of events 230 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Dizziness	8.2% 20/244 • Number of events 26 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.6% 23/497 • Number of events 30 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.5% 23/507 • Number of events 25 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	5.7% 43/751 • Number of events 51 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	5.3% 66/1248 • Number of events 81 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Nervous system disorders Hypoaesthesia	5.3% 13/244 • Number of events 15 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.8% 9/497 • Number of events 9 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.4% 12/507 • Number of events 13 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.3% 25/751 • Number of events 28 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.7% 34/1248 • Number of events 37 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Psychiatric disorders Depression	6.6% 16/244 • Number of events 17 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.6% 23/497 • Number of events 23 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.0% 15/507 • Number of events 16 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.1% 31/751 • Number of events 33 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	4.3% 54/1248 • Number of events 56 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Cough	8.6% 21/244 • Number of events 25 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	6.0% 30/497 • Number of events 31 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	6.3% 32/507 • Number of events 43 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	7.1% 53/751 • Number of events 68 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	6.7% 83/1248 • Number of events 99 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.1% 15/244 • Number of events 24 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.8% 9/497 • Number of events 11 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.8% 14/507 • Number of events 16 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.9% 29/751 • Number of events 40 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	3.0% 38/1248 • Number of events 51 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Respiratory, thoracic and mediastinal disorders Urticaria	5.3% 13/244 • Number of events 20 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.4% 7/497 • Number of events 7 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	0.79% 4/507 • Number of events 4 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	2.3% 17/751 • Number of events 24 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	1.9% 24/1248 • Number of events 31 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)
Vascular disorders Hypertension	7.0% 17/244 • Number of events 19 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	5.2% 26/497 • Number of events 28 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	5.1% 26/507 • Number of events 27 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	5.7% 43/751 • Number of events 46 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)	5.5% 69/1248 • Number of events 74 • Adverse events were collected from Visit 1 until Safety Follow-Up Visit (up to Week 196)

Additional Information

UCB

Cares

Phone: +1844 599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60