Trial Outcomes & Findings for Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip (NCT NCT02683239)

NCT ID: NCT02683239

Last Updated: 2023-10-13

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

5331 participants

Primary outcome timeframe

Baseline up to week 52

Results posted on

2023-10-13

Participant Flow

13,945 participants were screened. Of those, 5,331 met the eligibility criteria and were randomized to 1 of 7 treatment arms.

Participant milestones

Participant milestones
Measure	Fasinumab-matching Placebo Q4W/Q8W Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Overall Study STARTED	1260	971	975	214	1680	116	115
Overall Study COMPLETED	800	738	756	94	935	56	44
Overall Study NOT COMPLETED	460	233	219	120	745	60	71

Reasons for withdrawal

Reasons for withdrawal
Measure	Fasinumab-matching Placebo Q4W/Q8W Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Overall Study Protocol Violation	35	23	26	4	35	4	5
Overall Study Adverse Event	64	39	42	16	189	9	9
Overall Study Physician Decision	38	19	14	73	143	14	15
Overall Study Withdrawal by Subject	187	99	91	18	248	22	28
Overall Study Lost to Follow-up	77	24	25	7	88	8	11
Overall Study Death	9	5	8	0	12	1	0
Overall Study Lack of Efficacy	50	23	12	2	29	2	3
Overall Study Missing data	0	1	1	0	1	0	0

Baseline Characteristics

Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1260 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=971 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=975 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1680 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.	Total n=5331 Participants Total of all reporting groups
Age, Continuous	63.7 Years STANDARD_DEVIATION 9.24 • n=1260 Participants	65.0 Years STANDARD_DEVIATION 9.24 • n=971 Participants	65.1 Years STANDARD_DEVIATION 8.57 • n=975 Participants	65.3 Years STANDARD_DEVIATION 9.19 • n=214 Participants	62.9 Years STANDARD_DEVIATION 9.61 • n=1680 Participants	62.4 Years STANDARD_DEVIATION 8.38 • n=116 Participants	63.4 Years STANDARD_DEVIATION 9.89 • n=115 Participants	64.0 Years STANDARD_DEVIATION 9.28 • n=5331 Participants
Sex: Female, Male Female	913 Participants n=1260 Participants	723 Participants n=971 Participants	705 Participants n=975 Participants	149 Participants n=214 Participants	1237 Participants n=1680 Participants	83 Participants n=116 Participants	76 Participants n=115 Participants	3886 Participants n=5331 Participants
Sex: Female, Male Male	347 Participants n=1260 Participants	248 Participants n=971 Participants	270 Participants n=975 Participants	65 Participants n=214 Participants	443 Participants n=1680 Participants	33 Participants n=116 Participants	39 Participants n=115 Participants	1445 Participants n=5331 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	117 Participants n=1260 Participants	177 Participants n=971 Participants	182 Participants n=975 Participants	6 Participants n=214 Participants	124 Participants n=1680 Participants	8 Participants n=116 Participants	8 Participants n=115 Participants	622 Participants n=5331 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1139 Participants n=1260 Participants	791 Participants n=971 Participants	787 Participants n=975 Participants	207 Participants n=214 Participants	1547 Participants n=1680 Participants	108 Participants n=116 Participants	107 Participants n=115 Participants	4686 Participants n=5331 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=1260 Participants	3 Participants n=971 Participants	6 Participants n=975 Participants	1 Participants n=214 Participants	9 Participants n=1680 Participants	0 Participants n=116 Participants	0 Participants n=115 Participants	23 Participants n=5331 Participants
Race (NIH/OMB) American Indian or Alaska Native	19 Participants n=1260 Participants	50 Participants n=971 Participants	53 Participants n=975 Participants	0 Participants n=214 Participants	8 Participants n=1680 Participants	0 Participants n=116 Participants	1 Participants n=115 Participants	131 Participants n=5331 Participants
Race (NIH/OMB) Asian	25 Participants n=1260 Participants	7 Participants n=971 Participants	9 Participants n=975 Participants	0 Participants n=214 Participants	52 Participants n=1680 Participants	0 Participants n=116 Participants	0 Participants n=115 Participants	93 Participants n=5331 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=1260 Participants	0 Participants n=971 Participants	0 Participants n=975 Participants	0 Participants n=214 Participants	0 Participants n=1680 Participants	1 Participants n=116 Participants	0 Participants n=115 Participants	2 Participants n=5331 Participants
Race (NIH/OMB) Black or African American	156 Participants n=1260 Participants	64 Participants n=971 Participants	66 Participants n=975 Participants	16 Participants n=214 Participants	213 Participants n=1680 Participants	15 Participants n=116 Participants	12 Participants n=115 Participants	542 Participants n=5331 Participants
Race (NIH/OMB) White	996 Participants n=1260 Participants	759 Participants n=971 Participants	738 Participants n=975 Participants	190 Participants n=214 Participants	1352 Participants n=1680 Participants	99 Participants n=116 Participants	102 Participants n=115 Participants	4236 Participants n=5331 Participants
Race (NIH/OMB) More than one race	0 Participants n=1260 Participants	0 Participants n=971 Participants	0 Participants n=975 Participants	0 Participants n=214 Participants	0 Participants n=1680 Participants	0 Participants n=116 Participants	0 Participants n=115 Participants	0 Participants n=5331 Participants
Race (NIH/OMB) Unknown or Not Reported	63 Participants n=1260 Participants	91 Participants n=971 Participants	109 Participants n=975 Participants	8 Participants n=214 Participants	55 Participants n=1680 Participants	1 Participants n=116 Participants	0 Participants n=115 Participants	327 Participants n=5331 Participants
Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Subscale Score	6.6 Score on a Scale STANDARD_DEVIATION 1.55 • n=214 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.	6.70 Score on a Scale STANDARD_DEVIATION 1.44 • n=214 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.	6.6 Score on a Scale STANDARD_DEVIATION 1.49 • n=217 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.	6.5 Score on a Scale STANDARD_DEVIATION 1.47 • n=213 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.	6.6 Score on a Scale STANDARD_DEVIATION 1.41 • n=213 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.	—	—	6.6 Score on a Scale STANDARD_DEVIATION 1.47 • n=1071 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.
WOMAC Physical Function Subscale Score	6.47 Score on a Scale STANDARD_DEVIATION 1.583 • n=207 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.	6.56 Score on a Scale STANDARD_DEVIATION 1.631 • n=212 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.	6.41 Score on a Scale STANDARD_DEVIATION 1.495 • n=212 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.	6.27 Score on a Scale STANDARD_DEVIATION 1.699 • n=208 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.	6.38 Score on a Scale STANDARD_DEVIATION 1.598 • n=209 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.	—	—	6.42 Score on a Scale STANDARD_DEVIATION 1.602 • n=1048 Participants • Baseline WOMAC score data were collected for index joint and only for participants in the sub-study.

PRIMARY outcome

Timeframe: Baseline up to week 52

Population: The safety analysis set for the evaluation of long-term safety (SAF-LTS) included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=966 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=974 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1677 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)	1055 Participants	840 Participants	885 Participants	185 Participants	1487 Participants	93 Participants	92 Participants

PRIMARY outcome

Timeframe: Baseline up to week 52

Population: The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=966 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=974 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1677 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With Any Serious TEAE	82 Participants	57 Participants	70 Participants	13 Participants	107 Participants	5 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline up to week 72

Population: The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated)

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=966 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=974 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1677 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With Any Adverse Event (AE) up to Week 72	1112 Participants	867 Participants	902 Participants	192 Participants	1570 Participants	106 Participants	106 Participants

PRIMARY outcome

Timeframe: Baseline up to week 72

Population: The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=966 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=974 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1677 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With Any Serious AE up to Week 72	173 Participants	138 Participants	176 Participants	44 Participants	413 Participants	28 Participants	26 Participants

PRIMARY outcome

Timeframe: Baseline up to week 52 and week 72

Population: The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=966 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=974 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1677 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With Adjudicated Arthropathy (AA) Week 52	23 Participants	52 Participants	62 Participants	25 Participants	238 Participants	14 Participants	8 Participants
Number of Participants With Adjudicated Arthropathy (AA) Week 72	32 Participants	71 Participants	89 Participants	27 Participants	303 Participants	18 Participants	13 Participants

PRIMARY outcome

Timeframe: Baseline up to week 52 and week 72

Population: The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=966 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=974 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1677 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria Week 52	0 Participants	1 Participants	3 Participants	1 Participants	20 Participants	1 Participants	1 Participants
Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria Week 72	0 Participants	1 Participants	5 Participants	1 Participants	31 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline up to week 72

Population: The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Any participant with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an adverse event of special interest (AESI).

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=966 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=974 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1677 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation	29 Participants	65 Participants	62 Participants	21 Participants	75 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline up to week 72

Population: The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=966 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=974 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1677 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With Sympathetic Nervous System (SNS) Dysfunction	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline up to weeks 52, 72, and end of study (52 weeks post last dose)

Population: The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

All joint replacement surgery events regardless of cause at weeks 52 and 72. An end of study phone contact was also conducted approximately 52 weeks following the last dose of study drug.

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=966 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=974 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1677 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery End of Study (52 weeks post-last dose)	79 Participants	81 Participants	118 Participants	30 Participants	309 Participants	18 Participants	15 Participants
Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery Week 52	37 Participants	27 Participants	37 Participants	15 Participants	109 Participants	8 Participants	4 Participants
Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery Week 72	55 Participants	55 Participants	71 Participants	23 Participants	197 Participants	11 Participants	9 Participants

PRIMARY outcome

Timeframe: Baseline to week 52

Population: The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the treatment period were reported. Clinical significance was determined by the investigator.

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=966 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=974 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1677 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52 Chemistry	403 Participants	365 Participants	403 Participants	105 Participants	717 Participants	36 Participants	34 Participants
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52 Urinalysis	32 Participants	42 Participants	45 Participants	2 Participants	55 Participants	1 Participants	1 Participants
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52 Hematology	195 Participants	236 Participants	241 Participants	28 Participants	304 Participants	7 Participants	11 Participants

PRIMARY outcome

Timeframe: End of treatment up to week 72

Population: The SAF-LTS included all randomized participants in the overall study who received any study drug; it was based on the treatment-as-received (as treated).

Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the post-treatment period were reported. Clinical significance was determined by the investigator.

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=966 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=974 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1677 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=116 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=115 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72 Chemistry	267 Participants	228 Participants	225 Participants	59 Participants	474 Participants	36 Participants	40 Participants
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72 Urinalysis	16 Participants	24 Participants	18 Participants	1 Participants	37 Participants	5 Participants	3 Participants
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72 Hematology	171 Participants	149 Participants	154 Participants	23 Participants	279 Participants	29 Participants	32 Participants

PRIMARY outcome

Timeframe: Baseline up to week 72

Population: The ADA analysis set for the long-term safety population included all participants who received any study drug (SAF-LTS) and had at least 1 non-missing ADA result following the first dose of study drug.

Immunogenicity was characterized by ADA responses \& titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses less than (\<) 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, greater than or equal to (≥) 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the fasinumab ADA assay post first dose when baseline results = negative or missing.

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1153 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=911 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=929 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=208 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=1603 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W n=111 Participants Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W n=105 Participants Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With Anti-drug Antibody (ADA) up to Week 72 Treatment-Boosted Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Anti-drug Antibody (ADA) up to Week 72 Treatment-Emergent Response	16 Participants	10 Participants	10 Participants	2 Participants	19 Participants	1 Participants	0 Participants
Number of Participants With Anti-drug Antibody (ADA) up to Week 72 ADA Negative Status	1115 Participants	885 Participants	907 Participants	200 Participants	1547 Participants	108 Participants	104 Participants
Number of Participants With Anti-drug Antibody (ADA) up to Week 72 Pre-existing Immunoreactivity	22 Participants	16 Participants	12 Participants	6 Participants	37 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: The full analysis set for the efficacy substudy (FAS-Substudy) included all randomized participants in the efficacy substudy. Here, Number of Participants Analyzed = Number of participants within a specified category.

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=176 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=181 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=190 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=176 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=179 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score	-1.55 Score on a Scale Standard Error 0.178	-2.28 Score on a Scale Standard Error 0.175	-2.77 Score on a Scale Standard Error 0.171	-2.78 Score on a Scale Standard Error 0.174	-2.59 Score on a Scale Standard Error 0.174	—	—

PRIMARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=175 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=181 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=188 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=174 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=177 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score	-1.35 Score on a Scale Standard Error 0.177	-2.09 Score on a Scale Standard Error 0.175	-2.55 Score on a Scale Standard Error 0.173	-2.61 Score on a Scale Standard Error 0.177	-2.48 Score on a Scale Standard Error 0.177	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

The PGA of OA is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=181 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=183 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=193 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=177 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=180 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Change From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis	-0.66 Score on a Scale Standard Error 0.070	-0.87 Score on a Scale Standard Error 0.071	-0.93 Score on a Scale Standard Error 0.069	-0.99 Score on a Scale Standard Error 0.071	-0.96 Score on a Scale Standard Error 0.072	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Fasinumab-matching Placebo Q4W/Q8W n=214 Participants Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1 mg SC Q8W n=215 Participants Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1 mg SC Q4W n=217 Participants Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3 mg SC Q4W n=214 Participants Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q8W n=214 Participants Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6 mg SC Q4W Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9 mg SC Q4W Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Number of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score	76 Participants	108 Participants	126 Participants	118 Participants	114 Participants	—	—

Adverse Events

Fasinumab-matching Placebo Q4W/Q8W

Serious events: 183 serious events

Other events: 988 other events

Deaths: 9 deaths

Fasinumab 1mg SC Q8W

Serious events: 146 serious events

Other events: 793 other events

Deaths: 5 deaths

Fasinumab 1mg SC Q4W

Serious events: 186 serious events

Other events: 817 other events

Deaths: 8 deaths

Fasinumab 3mg SC Q4W

Serious events: 51 serious events

Other events: 181 other events

Deaths: 0 deaths

Fasinumab 6mg SC Q8W

Serious events: 441 serious events

Other events: 1447 other events

Deaths: 12 deaths

Fasinumab 6mg SC Q4W

Serious events: 29 serious events

Other events: 95 other events

Deaths: 1 deaths

Fasinumab 9mg SC Q4W

Serious events: 26 serious events

Other events: 88 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 participants at risk Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1mg SC Q8W n=966 participants at risk Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1mg SC Q4W n=974 participants at risk Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3mg SC Q4W n=214 participants at risk Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6mg SC Q8W n=1677 participants at risk Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6mg SC Q4W n=116 participants at risk Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9mg SC Q4W n=115 participants at risk Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Endocrine disorders Thyroid mass	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Eye disorders Angle closure glaucoma	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Eye disorders Cataract	0.16% 2/1257 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)
Eye disorders Macular hole	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Eye disorders Open angle glaucoma	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Eye disorders Retinal detachment	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Abdominal adhesions	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Abdominal hernia	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Abdominal pain	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Surgical and medical procedures Joint arthroplasty	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations COVID-19	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.41% 4/966 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Bronchitis haemophilus	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Gastroenteritis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign renal neoplasm	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/966 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder adenocarcinoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer stage I	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.08% 1/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage III	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell cancer of the renal pelvis and ureter	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Auditory nerve disorder	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Carpal tunnel syndrome	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/966 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.30% 5/1677 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	1.7% 2/115 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Cauda equina syndrome	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Cerebral haemorrhage	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Cerebral ischaemia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Cerebrospinal fistula	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Cerebrovascular accident	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Dizziness	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/974 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Facial spasm	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Ischaemic stroke	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	1.7% 2/116 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Lacunar infarction	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Lumbar radiculopathy	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Myelopathy	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Neuropathy peripheral	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Paraesthesia	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Radiculopathy	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.18% 3/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Sciatica	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Syncope	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Transient ischaemic attack	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.41% 4/974 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Vascular encephalopathy	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Vertebrobasilar insufficiency	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Product Issues Device loosening	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Product Issues Device occlusion	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Psychiatric disorders Alcohol abuse	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Psychiatric disorders Depression	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Psychiatric disorders Mood disorder due to a general medical condition	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Acute kidney injury	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Bladder stenosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Calculus bladder	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Calculus urinary	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Nephrolithiasis	0.16% 2/1257 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/966 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Urinary incontinence	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Urinary retention	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Reproductive system and breast disorders Benign prostatic hyperplasia	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/966 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Reproductive system and breast disorders Breast mass	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Reproductive system and breast disorders Cystocele	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Reproductive system and breast disorders Genital haemorrhage	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Reproductive system and breast disorders Ovarian cyst	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Reproductive system and breast disorders Uterine adhesions	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Reproductive system and breast disorders Uterine prolapse	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Reproductive system and breast disorders Vaginal prolapse	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.24% 3/1257 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Epiglottic cyst	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.08% 1/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/974 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Skin and subcutaneous tissue disorders Dermatitis allergic	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Skin and subcutaneous tissue disorders Lichen planus	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Skin and subcutaneous tissue disorders Skin ulcer	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Surgical and medical procedures Hip arthroplasty	0.72% 9/1257 • Number of events 9 • From time of randomization to end of post follow-up period (Week 100)	0.83% 8/966 • Number of events 8 • From time of randomization to end of post follow-up period (Week 100)	0.92% 9/974 • Number of events 10 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.24% 4/1677 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	1.7% 2/116 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Surgical and medical procedures Knee arthroplasty	1.1% 14/1257 • Number of events 15 • From time of randomization to end of post follow-up period (Week 100)	1.4% 14/966 • Number of events 14 • From time of randomization to end of post follow-up period (Week 100)	1.4% 14/974 • Number of events 14 • From time of randomization to end of post follow-up period (Week 100)	2.3% 5/214 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	1.8% 30/1677 • Number of events 33 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Deep vein thrombosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Hypertension	0.40% 5/1257 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Hypertensive crisis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Hypertensive urgency	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Hypotension	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Peripheral venous disease	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Venous thrombosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Venous thrombosis limb	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.18% 3/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.18% 3/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Joint stiffness	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Knee deformity	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Polymyositis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Spinal stenosis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.18% 3/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Surgical and medical procedures Knee operation	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Surgical and medical procedures Cataract operation	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Pneumonia haemophilus	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Pneumonia pneumococcal	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Post procedural infection	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Abscess intestinal	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Abscess limb	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Appendicitis perforated	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Arthritis bacterial	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Bronchitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations COVID-19 pneumonia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Device related infection	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Endocarditis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Endocarditis bacterial	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Gastroenteritis adenovirus	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Gastroenteritis viral	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Hepatitis C	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Infective exacerbation of bronchiectasis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Influenza	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Orchitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Otitis externa	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Post procedural cellulitis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Postoperative wound infection	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Vestibular neuronitis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Atrial flutter	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Cardio-respiratory arrest	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Acute coronary syndrome	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Bundle branch block right	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Cardiac failure	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Cardiac failure acute	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Cardiac failure congestive	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Mitral valve incompetence	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Concussion	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Radius fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Internal hernia	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Contusion	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Deep vein thrombosis postoperative	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Foot fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Incisional hernia	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Joint injury	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Patella fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Periprosthetic fracture	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Post procedural constipation	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Post procedural pulmonary embolism	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Procedural pain	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Tendon injury	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Nasal septum disorder	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic neuroma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory carcinoma of breast stage III	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal neoplasm	0.08% 1/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial spreading melanoma stage unspecified	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Carotid artery stenosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Hypoaesthesia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Vertebral artery stenosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Axonal neuropathy	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Carotid artery occlusion	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Cervical radiculopathy	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Intracranial aneurysm	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Loss of consciousness	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Myasthenia gravis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Neuralgic amyotrophy	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Restless legs syndrome	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Spinal cord compression	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Subarachnoid haemorrhage	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Large intestine polyp	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Volvulus	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Abdominal discomfort	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Constipation	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Diarrhoea	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Faecaloma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Gastric ulcer	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Pancreatitis acute	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Peptic ulcer	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Bladder prolapse	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Renal failure	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Stress urinary incontinence	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Renal and urinary disorders Urethral stenosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Reproductive system and breast disorders Endometrial thickening	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Reproductive system and breast disorders Rectocele	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Reproductive system and breast disorders Uterine polyp	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Haematemesis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Product Issues Device dislocation	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Aortic dilatation	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Giant cell arteritis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Haematoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Lymphoedema	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Peripheral vascular disorder	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Varicose vein	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Ear and labyrinth disorders Vertigo positional	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
General disorders Asthenia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
General disorders Oedema peripheral	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
General disorders Pyrexia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Immune system disorders Anaphylactic reaction	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Immune system disorders Sarcoidosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Investigations Liver function test abnormal	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Investigations Diagnostic procedure	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Psychiatric disorders Major depression	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Psychiatric disorders Psychotic disorder	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Eye disorders Borderline glaucoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Eye disorders Maculopathy	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Eye disorders Visual impairment	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Metabolism and nutrition disorders Dehydration	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Metabolism and nutrition disorders Gout	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Metabolism and nutrition disorders Hyperglycaemia	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Skin and subcutaneous tissue disorders Idiopathic angioedema	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Abdominal hernia obstructive	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Cerebral infarction	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Aortic dissection	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Immune system disorders Anaphylactic shock	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Hepatobiliary disorders Hepatic lesion	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Blood and lymphatic system disorders Anaemia	0.32% 4/1257 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Acute myocardial infarction	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/966 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.24% 4/1677 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Angina pectoris	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.24% 4/1677 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Angina unstable	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Arrhythmia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Atrial fibrillation	0.24% 3/1257 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	1.4% 3/214 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.36% 6/1677 • Number of events 6 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Atrioventricular block second degree	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Bradycardia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Cardiac failure chronic	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Cardiomyopathy	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Coronary artery disease	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.41% 4/966 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Left ventricular failure	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Myocardial infarction	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Myocardial ischaemia	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/966 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Sinus node dysfunction	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Cardiac disorders Ventricular tachycardia	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Ear and labyrinth disorders Vertigo	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Ear and labyrinth disorders Vestibular ataxia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Ear and labyrinth disorders Vestibular disorder	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Abdominal pain upper	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Abdominal wall haematoma	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Chronic gastritis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Colitis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Diaphragmatic hernia	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Gastritis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Haemorrhoids	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Hernial eventration	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Hiatus hernia	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Fall	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.18% 3/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Ileus paralytic	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Incarcerated inguinal hernia	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Inguinal hernia	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Mechanical ileus	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Femoral neck fracture	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.18% 3/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Terminal ileitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
General disorders Chest pain	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
General disorders Death	0.24% 3/1257 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/966 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/974 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
General disorders Peripheral swelling	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Hepatobiliary disorders Autoimmune hepatitis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Hepatobiliary disorders Bile duct stone	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Hepatobiliary disorders Cholecystitis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Hepatobiliary disorders Cholecystitis acute	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Hepatobiliary disorders Cholelithiasis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Immune system disorders Hypersensitivity	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Appendicitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/974 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Cellulitis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/974 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.36% 6/1677 • Number of events 6 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Cellulitis staphylococcal	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Cholecystitis infective	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Cystitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Dengue fever	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Diverticulitis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/966 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Localised infection	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Lower respiratory tract infection	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Mastitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Parainfluenzae virus infection	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Peritonitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Pneumonia	0.40% 5/1257 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.42% 7/1677 • Number of events 7 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Pneumonia bacterial	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Pulmonary tuberculosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Pyelonephritis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Respiratory tract infection viral	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Sepsis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Septic shock	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Urinary tract infection	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Urinary tract infection bacterial	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Urosepsis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Wound infection	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Ankle fracture	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Femur fracture	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.24% 4/1677 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Hip fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.18% 3/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Humerus fracture	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Joint dislocation	0.24% 3/1257 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.21% 2/974 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Meniscus injury	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.30% 5/1677 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Multiple injuries	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Muscle strain	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Rib fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Road traffic accident	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Stress fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Subdural haemorrhage	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Tendon dislocation	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.24% 4/1677 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Investigations Blood creatine phosphokinase MB increased	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Investigations Blood creatine phosphokinase increased	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Investigations Transaminases increased	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Metabolism and nutrition disorders Diabetes mellitus	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Metabolism and nutrition disorders Diabetic ketoacidosis	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Metabolism and nutrition disorders Hyponatraemia	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Metabolism and nutrition disorders Metabolic syndrome	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 17/1257 • Number of events 18 • From time of randomization to end of post follow-up period (Week 100)	1.7% 16/966 • Number of events 18 • From time of randomization to end of post follow-up period (Week 100)	2.4% 23/974 • Number of events 25 • From time of randomization to end of post follow-up period (Week 100)	2.3% 5/214 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	3.4% 57/1677 • Number of events 62 • From time of randomization to end of post follow-up period (Week 100)	2.6% 3/116 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	1.7% 2/115 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Arthritis reactive	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.24% 4/1677 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Foot deformity	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/974 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.47% 1/214 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.18% 3/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Limb mass	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/974 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.30% 5/1677 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Muscular weakness	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.93% 2/214 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.06% 1/1677 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.95% 12/1257 • Number of events 14 • From time of randomization to end of post follow-up period (Week 100)	1.1% 11/966 • Number of events 12 • From time of randomization to end of post follow-up period (Week 100)	1.8% 18/974 • Number of events 19 • From time of randomization to end of post follow-up period (Week 100)	3.7% 8/214 • Number of events 9 • From time of randomization to end of post follow-up period (Week 100)	2.6% 43/1677 • Number of events 44 • From time of randomization to end of post follow-up period (Week 100)	3.4% 4/116 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.18% 3/1677 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Rapidly progressive osteoarthritis	0.64% 8/1257 • Number of events 9 • From time of randomization to end of post follow-up period (Week 100)	2.4% 23/966 • Number of events 23 • From time of randomization to end of post follow-up period (Week 100)	2.8% 27/974 • Number of events 31 • From time of randomization to end of post follow-up period (Week 100)	4.7% 10/214 • Number of events 11 • From time of randomization to end of post follow-up period (Week 100)	9.4% 157/1677 • Number of events 200 • From time of randomization to end of post follow-up period (Week 100)	6.9% 8/116 • Number of events 10 • From time of randomization to end of post follow-up period (Week 100)	5.2% 6/115 • Number of events 7 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.31% 3/974 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.60% 10/1677 • Number of events 10 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Subchondral insufficiency fracture	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	1.3% 21/1677 • Number of events 21 • From time of randomization to end of post follow-up period (Week 100)	1.7% 2/116 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.12% 2/1677 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.86% 1/116 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Tendon pain	0.00% 0/1257 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.16% 2/1257 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/966 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.10% 1/974 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.08% 1/1257 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/966 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/974 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/214 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/1677 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/116 • From time of randomization to end of post follow-up period (Week 100)	0.00% 0/115 • From time of randomization to end of post follow-up period (Week 100)

Other adverse events

Other adverse events
Measure	Fasinumab-matching Placebo Q4W/Q8W n=1257 participants at risk Participants received fasinumab matching placebo SC injection, Q4W or Q8W from Day 1 up to 52 weeks.	Fasinumab 1mg SC Q8W n=966 participants at risk Participants received fasinumab 1 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 1mg SC Q4W n=974 participants at risk Participants received fasinumab 1 mg SC injection Q4W from day 1 up to 52 weeks.	Fasinumab 3mg SC Q4W n=214 participants at risk Participants received fasinumab 3 mg SC injection, Q4W from day 1 up to 52 weeks.	Fasinumab 6mg SC Q8W n=1677 participants at risk Participants received fasinumab 6 mg SC injection, Q8W from day 1 up to 52 weeks.	Fasinumab 6mg SC Q4W n=116 participants at risk Participants received fasinumab 6 mg SC injection Q4W from day 1 up to 37 weeks of 52-week treatment period.	Fasinumab 9mg SC Q4W n=115 participants at risk Participants received fasinumab 9 mg SC injection, Q4W from day 1 up to 37 weeks of 52-week treatment period.
Musculoskeletal and connective tissue disorders Arthralgia	32.9% 413/1257 • Number of events 771 • From time of randomization to end of post follow-up period (Week 100)	35.9% 347/966 • Number of events 636 • From time of randomization to end of post follow-up period (Week 100)	35.9% 350/974 • Number of events 633 • From time of randomization to end of post follow-up period (Week 100)	32.2% 69/214 • Number of events 109 • From time of randomization to end of post follow-up period (Week 100)	42.3% 710/1677 • Number of events 1358 • From time of randomization to end of post follow-up period (Week 100)	45.7% 53/116 • Number of events 115 • From time of randomization to end of post follow-up period (Week 100)	39.1% 45/115 • Number of events 82 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Back pain	16.2% 204/1257 • Number of events 363 • From time of randomization to end of post follow-up period (Week 100)	21.4% 207/966 • Number of events 336 • From time of randomization to end of post follow-up period (Week 100)	19.0% 185/974 • Number of events 301 • From time of randomization to end of post follow-up period (Week 100)	14.0% 30/214 • Number of events 37 • From time of randomization to end of post follow-up period (Week 100)	16.9% 283/1677 • Number of events 519 • From time of randomization to end of post follow-up period (Week 100)	12.1% 14/116 • Number of events 24 • From time of randomization to end of post follow-up period (Week 100)	11.3% 13/115 • Number of events 18 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Pain in extremity	9.0% 113/1257 • Number of events 151 • From time of randomization to end of post follow-up period (Week 100)	11.8% 114/966 • Number of events 144 • From time of randomization to end of post follow-up period (Week 100)	12.7% 124/974 • Number of events 181 • From time of randomization to end of post follow-up period (Week 100)	7.5% 16/214 • Number of events 31 • From time of randomization to end of post follow-up period (Week 100)	9.0% 151/1677 • Number of events 215 • From time of randomization to end of post follow-up period (Week 100)	17.2% 20/116 • Number of events 29 • From time of randomization to end of post follow-up period (Week 100)	10.4% 12/115 • Number of events 42 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Myalgia	6.1% 77/1257 • Number of events 100 • From time of randomization to end of post follow-up period (Week 100)	6.2% 60/966 • Number of events 81 • From time of randomization to end of post follow-up period (Week 100)	6.0% 58/974 • Number of events 77 • From time of randomization to end of post follow-up period (Week 100)	5.1% 11/214 • Number of events 11 • From time of randomization to end of post follow-up period (Week 100)	6.0% 101/1677 • Number of events 127 • From time of randomization to end of post follow-up period (Week 100)	6.0% 7/116 • Number of events 7 • From time of randomization to end of post follow-up period (Week 100)	3.5% 4/115 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Osteoarthritis	5.9% 74/1257 • Number of events 101 • From time of randomization to end of post follow-up period (Week 100)	6.2% 60/966 • Number of events 87 • From time of randomization to end of post follow-up period (Week 100)	7.7% 75/974 • Number of events 101 • From time of randomization to end of post follow-up period (Week 100)	14.0% 30/214 • Number of events 38 • From time of randomization to end of post follow-up period (Week 100)	6.9% 116/1677 • Number of events 150 • From time of randomization to end of post follow-up period (Week 100)	6.0% 7/116 • Number of events 10 • From time of randomization to end of post follow-up period (Week 100)	5.2% 6/115 • Number of events 7 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Joint swelling	2.9% 37/1257 • Number of events 43 • From time of randomization to end of post follow-up period (Week 100)	3.3% 32/966 • Number of events 33 • From time of randomization to end of post follow-up period (Week 100)	3.6% 35/974 • Number of events 38 • From time of randomization to end of post follow-up period (Week 100)	7.0% 15/214 • Number of events 17 • From time of randomization to end of post follow-up period (Week 100)	8.5% 143/1677 • Number of events 183 • From time of randomization to end of post follow-up period (Week 100)	3.4% 4/116 • Number of events 6 • From time of randomization to end of post follow-up period (Week 100)	8.7% 10/115 • Number of events 12 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Headache	31.4% 395/1257 • Number of events 1445 • From time of randomization to end of post follow-up period (Week 100)	38.3% 370/966 • Number of events 948 • From time of randomization to end of post follow-up period (Week 100)	42.9% 418/974 • Number of events 1081 • From time of randomization to end of post follow-up period (Week 100)	35.5% 76/214 • Number of events 158 • From time of randomization to end of post follow-up period (Week 100)	33.0% 554/1677 • Number of events 1833 • From time of randomization to end of post follow-up period (Week 100)	29.3% 34/116 • Number of events 124 • From time of randomization to end of post follow-up period (Week 100)	26.1% 30/115 • Number of events 73 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Paraesthesia	3.3% 42/1257 • Number of events 54 • From time of randomization to end of post follow-up period (Week 100)	5.6% 54/966 • Number of events 66 • From time of randomization to end of post follow-up period (Week 100)	7.8% 76/974 • Number of events 95 • From time of randomization to end of post follow-up period (Week 100)	6.1% 13/214 • Number of events 18 • From time of randomization to end of post follow-up period (Week 100)	8.6% 144/1677 • Number of events 169 • From time of randomization to end of post follow-up period (Week 100)	5.2% 6/116 • Number of events 6 • From time of randomization to end of post follow-up period (Week 100)	7.8% 9/115 • Number of events 10 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Hypoaesthesia	2.8% 35/1257 • Number of events 43 • From time of randomization to end of post follow-up period (Week 100)	2.6% 25/966 • Number of events 32 • From time of randomization to end of post follow-up period (Week 100)	2.8% 27/974 • Number of events 31 • From time of randomization to end of post follow-up period (Week 100)	5.1% 11/214 • Number of events 14 • From time of randomization to end of post follow-up period (Week 100)	6.0% 100/1677 • Number of events 130 • From time of randomization to end of post follow-up period (Week 100)	4.3% 5/116 • Number of events 6 • From time of randomization to end of post follow-up period (Week 100)	7.0% 8/115 • Number of events 12 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Carpal tunnel syndrome	2.2% 28/1257 • Number of events 31 • From time of randomization to end of post follow-up period (Week 100)	4.3% 42/966 • Number of events 49 • From time of randomization to end of post follow-up period (Week 100)	5.0% 49/974 • Number of events 58 • From time of randomization to end of post follow-up period (Week 100)	7.9% 17/214 • Number of events 19 • From time of randomization to end of post follow-up period (Week 100)	6.9% 116/1677 • Number of events 135 • From time of randomization to end of post follow-up period (Week 100)	9.5% 11/116 • Number of events 12 • From time of randomization to end of post follow-up period (Week 100)	8.7% 10/115 • Number of events 16 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Nasopharyngitis	14.6% 184/1257 • Number of events 233 • From time of randomization to end of post follow-up period (Week 100)	19.6% 189/966 • Number of events 289 • From time of randomization to end of post follow-up period (Week 100)	21.7% 211/974 • Number of events 304 • From time of randomization to end of post follow-up period (Week 100)	20.1% 43/214 • Number of events 55 • From time of randomization to end of post follow-up period (Week 100)	13.4% 224/1677 • Number of events 279 • From time of randomization to end of post follow-up period (Week 100)	10.3% 12/116 • Number of events 12 • From time of randomization to end of post follow-up period (Week 100)	15.7% 18/115 • Number of events 21 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Upper respiratory tract infection	11.3% 142/1257 • Number of events 198 • From time of randomization to end of post follow-up period (Week 100)	8.5% 82/966 • Number of events 103 • From time of randomization to end of post follow-up period (Week 100)	9.1% 89/974 • Number of events 113 • From time of randomization to end of post follow-up period (Week 100)	7.9% 17/214 • Number of events 17 • From time of randomization to end of post follow-up period (Week 100)	13.1% 220/1677 • Number of events 297 • From time of randomization to end of post follow-up period (Week 100)	12.9% 15/116 • Number of events 18 • From time of randomization to end of post follow-up period (Week 100)	8.7% 10/115 • Number of events 13 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Urinary tract infection	10.0% 126/1257 • Number of events 171 • From time of randomization to end of post follow-up period (Week 100)	8.7% 84/966 • Number of events 107 • From time of randomization to end of post follow-up period (Week 100)	12.8% 125/974 • Number of events 161 • From time of randomization to end of post follow-up period (Week 100)	9.8% 21/214 • Number of events 26 • From time of randomization to end of post follow-up period (Week 100)	9.5% 160/1677 • Number of events 217 • From time of randomization to end of post follow-up period (Week 100)	7.8% 9/116 • Number of events 11 • From time of randomization to end of post follow-up period (Week 100)	5.2% 6/115 • Number of events 9 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Influenza	5.5% 69/1257 • Number of events 88 • From time of randomization to end of post follow-up period (Week 100)	5.6% 54/966 • Number of events 59 • From time of randomization to end of post follow-up period (Week 100)	6.1% 59/974 • Number of events 66 • From time of randomization to end of post follow-up period (Week 100)	4.7% 10/214 • Number of events 10 • From time of randomization to end of post follow-up period (Week 100)	6.1% 103/1677 • Number of events 119 • From time of randomization to end of post follow-up period (Week 100)	2.6% 3/116 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	0.87% 1/115 • Number of events 1 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Toothache	8.8% 110/1257 • Number of events 159 • From time of randomization to end of post follow-up period (Week 100)	9.4% 91/966 • Number of events 148 • From time of randomization to end of post follow-up period (Week 100)	12.1% 118/974 • Number of events 176 • From time of randomization to end of post follow-up period (Week 100)	5.1% 11/214 • Number of events 14 • From time of randomization to end of post follow-up period (Week 100)	7.0% 118/1677 • Number of events 188 • From time of randomization to end of post follow-up period (Week 100)	4.3% 5/116 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	2.6% 3/115 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Diarrhoea	4.6% 58/1257 • Number of events 67 • From time of randomization to end of post follow-up period (Week 100)	5.7% 55/966 • Number of events 67 • From time of randomization to end of post follow-up period (Week 100)	4.7% 46/974 • Number of events 61 • From time of randomization to end of post follow-up period (Week 100)	4.7% 10/214 • Number of events 10 • From time of randomization to end of post follow-up period (Week 100)	4.8% 81/1677 • Number of events 88 • From time of randomization to end of post follow-up period (Week 100)	11.2% 13/116 • Number of events 19 • From time of randomization to end of post follow-up period (Week 100)	3.5% 4/115 • Number of events 8 • From time of randomization to end of post follow-up period (Week 100)
General disorders Peripheral swelling	1.3% 16/1257 • Number of events 20 • From time of randomization to end of post follow-up period (Week 100)	1.1% 11/966 • Number of events 11 • From time of randomization to end of post follow-up period (Week 100)	2.1% 20/974 • Number of events 23 • From time of randomization to end of post follow-up period (Week 100)	2.3% 5/214 • Number of events 6 • From time of randomization to end of post follow-up period (Week 100)	4.8% 81/1677 • Number of events 97 • From time of randomization to end of post follow-up period (Week 100)	2.6% 3/116 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	9.6% 11/115 • Number of events 11 • From time of randomization to end of post follow-up period (Week 100)
Musculoskeletal and connective tissue disorders Rapidly progressive osteoarthritis	2.1% 26/1257 • Number of events 27 • From time of randomization to end of post follow-up period (Week 100)	5.3% 51/966 • Number of events 55 • From time of randomization to end of post follow-up period (Week 100)	7.2% 70/974 • Number of events 73 • From time of randomization to end of post follow-up period (Week 100)	7.9% 17/214 • Number of events 19 • From time of randomization to end of post follow-up period (Week 100)	10.1% 170/1677 • Number of events 214 • From time of randomization to end of post follow-up period (Week 100)	9.5% 11/116 • Number of events 11 • From time of randomization to end of post follow-up period (Week 100)	7.0% 8/115 • Number of events 10 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Dizziness	4.9% 61/1257 • Number of events 75 • From time of randomization to end of post follow-up period (Week 100)	4.7% 45/966 • Number of events 49 • From time of randomization to end of post follow-up period (Week 100)	4.9% 48/974 • Number of events 61 • From time of randomization to end of post follow-up period (Week 100)	3.3% 7/214 • Number of events 7 • From time of randomization to end of post follow-up period (Week 100)	5.6% 94/1677 • Number of events 109 • From time of randomization to end of post follow-up period (Week 100)	8.6% 10/116 • Number of events 17 • From time of randomization to end of post follow-up period (Week 100)	6.1% 7/115 • Number of events 10 • From time of randomization to end of post follow-up period (Week 100)
Nervous system disorders Sciatica	1.9% 24/1257 • Number of events 30 • From time of randomization to end of post follow-up period (Week 100)	2.8% 27/966 • Number of events 31 • From time of randomization to end of post follow-up period (Week 100)	3.4% 33/974 • Number of events 34 • From time of randomization to end of post follow-up period (Week 100)	4.7% 10/214 • Number of events 10 • From time of randomization to end of post follow-up period (Week 100)	4.5% 75/1677 • Number of events 88 • From time of randomization to end of post follow-up period (Week 100)	5.2% 6/116 • Number of events 7 • From time of randomization to end of post follow-up period (Week 100)	2.6% 3/115 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Bronchitis	4.2% 53/1257 • Number of events 55 • From time of randomization to end of post follow-up period (Week 100)	3.5% 34/966 • Number of events 35 • From time of randomization to end of post follow-up period (Week 100)	3.4% 33/974 • Number of events 36 • From time of randomization to end of post follow-up period (Week 100)	1.9% 4/214 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	4.4% 73/1677 • Number of events 79 • From time of randomization to end of post follow-up period (Week 100)	6.0% 7/116 • Number of events 7 • From time of randomization to end of post follow-up period (Week 100)	2.6% 3/115 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)
Infections and infestations Sinusitis	2.5% 31/1257 • Number of events 34 • From time of randomization to end of post follow-up period (Week 100)	2.4% 23/966 • Number of events 27 • From time of randomization to end of post follow-up period (Week 100)	2.1% 20/974 • Number of events 22 • From time of randomization to end of post follow-up period (Week 100)	2.3% 5/214 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	4.2% 71/1677 • Number of events 80 • From time of randomization to end of post follow-up period (Week 100)	6.0% 7/116 • Number of events 8 • From time of randomization to end of post follow-up period (Week 100)	2.6% 3/115 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)
Gastrointestinal disorders Nausea	2.9% 37/1257 • Number of events 41 • From time of randomization to end of post follow-up period (Week 100)	2.7% 26/966 • Number of events 27 • From time of randomization to end of post follow-up period (Week 100)	2.3% 22/974 • Number of events 24 • From time of randomization to end of post follow-up period (Week 100)	0.93% 2/214 • Number of events 3 • From time of randomization to end of post follow-up period (Week 100)	2.7% 45/1677 • Number of events 48 • From time of randomization to end of post follow-up period (Week 100)	4.3% 5/116 • Number of events 6 • From time of randomization to end of post follow-up period (Week 100)	6.1% 7/115 • Number of events 7 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Fall	4.3% 54/1257 • Number of events 62 • From time of randomization to end of post follow-up period (Week 100)	5.0% 48/966 • Number of events 54 • From time of randomization to end of post follow-up period (Week 100)	5.7% 56/974 • Number of events 62 • From time of randomization to end of post follow-up period (Week 100)	4.2% 9/214 • Number of events 10 • From time of randomization to end of post follow-up period (Week 100)	3.9% 65/1677 • Number of events 79 • From time of randomization to end of post follow-up period (Week 100)	4.3% 5/116 • Number of events 7 • From time of randomization to end of post follow-up period (Week 100)	4.3% 5/115 • Number of events 6 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Contusion	2.7% 34/1257 • Number of events 42 • From time of randomization to end of post follow-up period (Week 100)	3.6% 35/966 • Number of events 48 • From time of randomization to end of post follow-up period (Week 100)	3.7% 36/974 • Number of events 48 • From time of randomization to end of post follow-up period (Week 100)	3.3% 7/214 • Number of events 7 • From time of randomization to end of post follow-up period (Week 100)	3.7% 62/1677 • Number of events 70 • From time of randomization to end of post follow-up period (Week 100)	1.7% 2/116 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	7.0% 8/115 • Number of events 9 • From time of randomization to end of post follow-up period (Week 100)
Vascular disorders Hypertension	4.3% 54/1257 • Number of events 56 • From time of randomization to end of post follow-up period (Week 100)	5.6% 54/966 • Number of events 59 • From time of randomization to end of post follow-up period (Week 100)	4.8% 47/974 • Number of events 51 • From time of randomization to end of post follow-up period (Week 100)	3.3% 7/214 • Number of events 8 • From time of randomization to end of post follow-up period (Week 100)	4.8% 80/1677 • Number of events 84 • From time of randomization to end of post follow-up period (Week 100)	1.7% 2/116 • Number of events 2 • From time of randomization to end of post follow-up period (Week 100)	3.5% 4/115 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)
General disorders Oedema peripheral	2.5% 32/1257 • Number of events 38 • From time of randomization to end of post follow-up period (Week 100)	2.7% 26/966 • Number of events 29 • From time of randomization to end of post follow-up period (Week 100)	2.5% 24/974 • Number of events 25 • From time of randomization to end of post follow-up period (Week 100)	4.2% 9/214 • Number of events 9 • From time of randomization to end of post follow-up period (Week 100)	5.7% 95/1677 • Number of events 112 • From time of randomization to end of post follow-up period (Week 100)	9.5% 11/116 • Number of events 11 • From time of randomization to end of post follow-up period (Week 100)	4.3% 5/115 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)
Injury, poisoning and procedural complications Limb injury	1.5% 19/1257 • Number of events 19 • From time of randomization to end of post follow-up period (Week 100)	2.2% 21/966 • Number of events 28 • From time of randomization to end of post follow-up period (Week 100)	3.1% 30/974 • Number of events 31 • From time of randomization to end of post follow-up period (Week 100)	1.4% 3/214 • Number of events 4 • From time of randomization to end of post follow-up period (Week 100)	2.2% 37/1677 • Number of events 41 • From time of randomization to end of post follow-up period (Week 100)	4.3% 5/116 • Number of events 5 • From time of randomization to end of post follow-up period (Week 100)	5.2% 6/115 • Number of events 7 • From time of randomization to end of post follow-up period (Week 100)

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc

Phone: 844-734-6643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER