Trial Outcomes & Findings for A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip (NCT NCT03161093)

Last Updated: 2022-11-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3307 participants

Primary outcome timeframe

Baseline to Week 16

Results posted on

2022-11-14

Participant Flow

A total of 9157 participants were screened. Of those, 5850 were screen failures. 3307 participants were randomized into the study.

Participant milestones

Participant milestones
Measure	Placebo Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Naproxen Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 3mg Q4W Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID	Fasinumab 6mg Q8W Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID
Overall Study STARTED	354	1063	551	1054	145	140
Overall Study As Treated	352	1056	554	1052	145	139
Overall Study COMPLETED	299	919	465	867	102	99
Overall Study NOT COMPLETED	55	144	86	187	43	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Naproxen Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 3mg Q4W Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID	Fasinumab 6mg Q8W Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID
Overall Study Protocol Violation	11	14	6	13	1	0
Overall Study Adverse Event	5	21	16	35	2	1
Overall Study Lack of Efficacy	9	13	9	24	4	1
Overall Study Physician Decision	0	1	0	2	17	15
Overall Study Withdrawal by Subject	24	73	44	97	11	10
Overall Study Lost to Follow-up	3	12	4	7	8	13
Overall Study Death	3	9	7	9	0	0
Overall Study Unknown - Not reported	0	1	0	0	0	1

Baseline Characteristics

A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=354 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Naproxen n=1063 Participants Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID	Fasinumab 1 mg SC Q8W n=551 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1054 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 3mg Q4W n=145 Participants Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID	Fasinumab 6mg Q8W n=140 Participants Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID	Total n=3307 Participants Total of all reporting groups
Age, Customized 18-64 years	212 Participants n=5 Participants	608 Participants n=7 Participants	300 Participants n=5 Participants	584 Participants n=4 Participants	91 Participants n=21 Participants	81 Participants n=8 Participants	1876 Participants n=8 Participants
Age, Customized 65 - 84 years	140 Participants n=5 Participants	449 Participants n=7 Participants	247 Participants n=5 Participants	463 Participants n=4 Participants	53 Participants n=21 Participants	57 Participants n=8 Participants	1409 Participants n=8 Participants
Age, Customized 85 years and over	2 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	22 Participants n=8 Participants
Sex: Female, Male Female	265 Participants n=5 Participants	807 Participants n=7 Participants	419 Participants n=5 Participants	793 Participants n=4 Participants	96 Participants n=21 Participants	98 Participants n=8 Participants	2478 Participants n=8 Participants
Sex: Female, Male Male	89 Participants n=5 Participants	256 Participants n=7 Participants	132 Participants n=5 Participants	261 Participants n=4 Participants	49 Participants n=21 Participants	42 Participants n=8 Participants	829 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	26 Participants n=7 Participants	13 Participants n=5 Participants	38 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	101 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	339 Participants n=5 Participants	1032 Participants n=7 Participants	537 Participants n=5 Participants	1015 Participants n=4 Participants	139 Participants n=21 Participants	134 Participants n=8 Participants	3196 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	10 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	35 Participants n=7 Participants	29 Participants n=5 Participants	37 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	116 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	109 Participants n=5 Participants	315 Participants n=7 Participants	166 Participants n=5 Participants	308 Participants n=4 Participants	47 Participants n=21 Participants	47 Participants n=8 Participants	992 Participants n=8 Participants
Race (NIH/OMB) White	211 Participants n=5 Participants	633 Participants n=7 Participants	307 Participants n=5 Participants	630 Participants n=4 Participants	89 Participants n=21 Participants	86 Participants n=8 Participants	1956 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants	79 Participants n=7 Participants	48 Participants n=5 Participants	79 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	241 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Modified Full Analysis Set (mFAS) analysis population; The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.

Outcome measures

Outcome measures
Measure	Placebo n=155 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=522 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo	-1.82 Score on a scale Standard Error 0.162	-2.49 Score on a scale Standard Error 0.098	—	—

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.

Outcome measures

Outcome measures
Measure	Placebo n=155 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=521 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo	-1.71 Score on a scale Standard Error 0.161	-2.42 Score on a scale Standard Error 0.096	—	—

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.

Outcome measures

Outcome measures
Measure	Placebo n=80 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=254 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo	-2.09 Score on a scale Standard Error 0.231	-2.19 Score on a scale Standard Error 0.144	—	—

PRIMARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Placebo n=80 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=254 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo	-1.91 Score on a scale Standard Error 0.223	-2.09 Score on a scale Standard Error 0.137	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

The Patient Global Assessment of OA (PGA) 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	Placebo n=156 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=526 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo	-0.64 Score on a scale Standard Error 0.064	-0.92 Score on a scale Standard Error 0.040	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

The Patient Global Assessment of OA (PGA) 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	Placebo n=492 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=526 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen	-0.78 Score on a scale Standard Error 0.040	-0.92 Score on a scale Standard Error 0,040	—	—

SECONDARY outcome

Timeframe: Baseline to Week 44

The Patient Global Assessment of OA (PGA) 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	Placebo n=123 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=394 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo	-0.60 Score on a scale Standard Error 0.074	-0.79 Score on a scale Standard Error 0.043	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Placebo n=214 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=639 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores	43.9 Percentage of participants	56.2 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Placebo n=644 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=639 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores	50.5 Percentage of participants	56.2 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Placebo n=345 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=360 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen	-2.42 Score on a scale Standard Deviation 2.095	-2.88 Score on a scale Standard Deviation 2.099	—	—

SECONDARY outcome

Timeframe: Baseline to Week 44

Outcome measures

Outcome measures
Measure	Placebo n=122 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=391 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo	-1.69 Score on a scale Standard Error 0.188	-2.20 Score on a scale Standard Error 0.114	—	—

SECONDARY outcome

Timeframe: Baseline to Week 44

Outcome measures

Outcome measures
Measure	Placebo n=381 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=391 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen	-2.15 Score on a scale Standard Error 0.115	-2.20 Score on a scale Standard Error 0.114	—	—

SECONDARY outcome

Timeframe: Baseline to average score across weeks 4, 8, 12 and 16

Outcome measures

Outcome measures
Measure	Placebo n=192 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=595 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo	-1.37 Score on a scale Standard Error 0.137	-2.25 Score on a scale Standard Error 0.088	—	—

SECONDARY outcome

Timeframe: Baseline to average score across weeks 36, 40 and 44

Outcome measures

Outcome measures
Measure	Placebo n=133 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=426 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo	-1.50 Score on a scale Standard Error 0.172	-1.99 Score on a scale Standard Error 0.113	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Placebo n=485 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=521 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen	-1.98 Score on a scale Standard Error 0.101	-2.42 Score on a scale Standard Error 0.096	—	—

SECONDARY outcome

Timeframe: Baseline to Week 44

Outcome measures

Outcome measures
Measure	Placebo n=122 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=390 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo	-1.60 Score on a scale Standard Error 0.186	-2.07 Score on a scale Standard Error 0.109	—	—

SECONDARY outcome

Timeframe: Baseline to Week 44

Outcome measures

Outcome measures
Measure	Placebo n=378 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=390 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen	-2.00 Score on a scale Standard Error 0.113	-2.07 Score on a scale Standard Error 0.109	—	—

SECONDARY outcome

Timeframe: Baseline to average score across weeks 4, 8, 12 and 16

Outcome measures

Outcome measures
Measure	Placebo n=192 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=596 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo	-1.46 Score on a scale Standard Error 0.140	-2.30 Score on a scale Standard Error 0.090	—	—

SECONDARY outcome

Timeframe: Baseline to average score across weeks 36, 40 and 44

Outcome measures

Outcome measures
Measure	Placebo n=133 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=427 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo	-1.57 Score on a scale Standard Error 0.184	-2.06 Score on a scale Standard Error 0.118	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

The Patient Global Assessment of OA (PGA) 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	Placebo n=80 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=257 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo	-0.79 Score on a scale Standard Error 0.094	-0.77 Score on a scale Standard Error 0.057	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

The Patient Global Assessment of OA (PGA) 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	Placebo n=245 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=257 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen	-0.82 Score on a scale Standard Error 0.057	-0.77 Score on a scale Standard Error 0.057	—	—

SECONDARY outcome

Timeframe: Baseline to Week 44

The Patient Global Assessment of OA (PGA) 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	Placebo n=62 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=193 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo	-0.74 Score on a scale Standard Error 0.1115	-0.75 Score on a scale Standard Error 0.064	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Placebo n=170 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=171 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen	-2.41 Score on a scale Standard Error 0.155	-2.53 Score on a scale Standard Error 0.154	—	—

SECONDARY outcome

Timeframe: Baseline to Week 44

Outcome measures

Outcome measures
Measure	Placebo n=62 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=189 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo	-1.77 Score on a scale Standard Error 0.276	-1.99 Score on a scale Standard Error 0.163	—	—

SECONDARY outcome

Timeframe: Baseline to average score across weeks 4, 8, 12 and 16

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=291 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo	-1.61 Score on a scale Standard Error 0.196	-2.04 Score on a scale Standard Error 0.127	—	—

SECONDARY outcome

Timeframe: Baseline to average score across weeks 36, 40 and 44

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=210 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo	-1.62 Score on a scale Standard Error 0.261	-1.69 Score on a scale Standard Error 0.166	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Placebo n=241 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=254 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen	-2.04 Score on a scale Standard Error 0.140	-2.09 Score on a scale Standard Error 0.137	—	—

SECONDARY outcome

Timeframe: Baseline to Week 44

Outcome measures

Outcome measures
Measure	Placebo n=62 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=189 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo	-1.76 Score on a scale Standard Error 0.262	-1.90 Score on a scale Standard Error 0.157	—	—

SECONDARY outcome

Timeframe: Baseline to average score across weeks 4, 8, 12 and 16

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=291 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo	-1.73 Score on a scale Standard Error 0.202	-2.11 Score on a scale Standard Error 0.131	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=304 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores	53.9 Percentage of participants	52.3 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline to average score across weeks 36, 40 and 44

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=210 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo	-1.69 Score on a scale Standard Error 0.271	-1.80 Score on a scale Standard Error 0.169	—	—

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: The Year 1 safety analysis set (SAF - Year 1) includes all randomized patients from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time.

Outcome measures

Outcome measures
Measure	Placebo n=352 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=554 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1	4 Participants	27 Participants	40 Participants	102 Participants

SECONDARY outcome

Timeframe: First dose of study drug in Year 2 through week 104E

Population: The Year 2 safety analysis set (SAF - Year 2) includes all participants who received at least 1 dose of the Year 2 study drug; it is based on the treatment received during Year 2 (as treated); Here 'n' = Number of evaluable participants at a specified point in time.

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=402 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=193 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=371 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With AA (as Confirmed by Adjudication) - Year 2	2 Participants	7 Participants	11 Participants	53 Participants

SECONDARY outcome

Timeframe: Day 1 through week 104E (Extension)

Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.

Outcome measures

Outcome measures
Measure	Placebo n=353 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=553 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2	6 Participants	33 Participants	50 Participants	152 Participants

SECONDARY outcome

Timeframe: Baseline to Week 52

Outcome measures

Outcome measures
Measure	Placebo n=352 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=554 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1	0 Participants	1 Participants	2 Participants	7 Participants

SECONDARY outcome

Timeframe: First dose of study drug in Year 2 through week 104E

Outcome measures

Outcome measures
Measure	Placebo n=137 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=402 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=193 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=371 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With DA (as Confirmed by Adjudication) - Year 2	0 Participants	0 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 1 through week 104E

Outcome measures

Outcome measures
Measure	Placebo n=353 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=553 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2	0 Participants	1 Participants	2 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: The Year 1 safety analysis set (SAF - Year 1) includes all randomized participants from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time.

Outcome measures

Outcome measures
Measure	Placebo n=352 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=554 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Treatment Emergent Adverse Events (TEAEs) - Year 1	1063 Events	3641 Events	1985 Events	3901 Events

SECONDARY outcome

Timeframe: First dose of study drug in Year 2 through week 104E

Population: SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.

Outcome measures

Outcome measures
Measure	Placebo n=554 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=190 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=385 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of TEAEs - Year 2	973 Events	277 Events	808 Events	—

SECONDARY outcome

Timeframe: Day 1 through week 104E

Outcome measures

Outcome measures
Measure	Placebo n=353 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=553 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of TEAEs - Year 1 and Year 2	1317 Events	4348 Events	2271 Events	4712 Events

SECONDARY outcome

Timeframe: Baseline to Week 52

Outcome measures

Outcome measures
Measure	Placebo n=352 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=554 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: First dose of study drug in Year 2 through week 104E

Outcome measures

Outcome measures
Measure	Placebo n=554 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=190 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=385 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Day 1 through week 104E

Outcome measures

Outcome measures
Measure	Placebo n=353 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=553 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: Safety Analysis Set (SAF) - Year 1 included participants randomized to fasinumab 1 mg Q4W, fasinumab 1 mg Q8W, naproxen, and placebo. Here 'n' = Number of evaluable participants at the specified point in time.

Outcome measures

Outcome measures
Measure	Placebo n=352 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=554 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1	18 Participants	43 Participants	29 Participants	70 Participants

SECONDARY outcome

Timeframe: First dose of study drug in Year 2 through week 104E

Outcome measures

Outcome measures
Measure	Placebo n=554 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=190 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=385 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2	16 Participants	6 Participants	12 Participants	—

SECONDARY outcome

Timeframe: Day 1 through week 104E

Outcome measures

Outcome measures
Measure	Placebo n=353 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=553 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2	23 Participants	51 Participants	35 Participants	82 Participants

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: Safety Analysis Set (SAF)-Year 1. For participants with events, number of participant years is calculated up to the date of the first event; for participants without event, it corresponds to the length of the study participation in Year 1.

Outcome measures

Outcome measures
Measure	Placebo n=352 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=554 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1	12 Participants	33 Participants	31 Participants	67 Participants

SECONDARY outcome

Timeframe: First dose of study drug in Year 2 through week 104E

Outcome measures

Outcome measures
Measure	Placebo n=554 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=190 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=385 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With Any Type of All-Cause JR in Year 2	22 Participants	12 Participants	33 Participants	—

SECONDARY outcome

Timeframe: Day 1 through week 104E

Outcome measures

Outcome measures
Measure	Placebo n=353 Participants Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Fasinumab 1 mg SC Q4W n=1056 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID	Fasinumab 1 mg SC Q8W n=553 Participants Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID	Fasinumab 1 mg SC Q4W n=1052 Participants Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2	19 Participants	47 Participants	44 Participants	100 Participants

Adverse Events

Placebo

Serious events: 49 serious events

Other events: 215 other events

Deaths: 5 deaths

Naproxen

Serious events: 103 serious events

Other events: 687 other events

Deaths: 13 deaths

Fasinumab 1mg Q8W

Serious events: 81 serious events

Other events: 382 other events

Deaths: 12 deaths

Fasinumab 1mg Q4W

Serious events: 175 serious events

Other events: 727 other events

Deaths: 13 deaths

Fasinumab 3mg Q4W

Serious events: 7 serious events

Other events: 41 other events

Deaths: 0 deaths

Fasinumab 6mg Q8W

Serious events: 6 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=352 participants at risk Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Naproxen n=1056 participants at risk Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID	Fasinumab 1mg Q8W n=554 participants at risk Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID	Fasinumab 1mg Q4W n=1052 participants at risk Fasinumab 1 mg SC Q4W and naproxen-matching placebo PO, BID	Fasinumab 3mg Q4W n=145 participants at risk Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID	Fasinumab 6mg Q8W n=139 participants at risk Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Respiratory, thoracic and mediastinal disorders Apnoea	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.36% 2/554 • Number of events 2 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Congenital, familial and genetic disorders Hydrocele	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Psychiatric disorders Pseudodementia	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Immune system disorders Anaphylactic reaction	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Product Issues Device dislocation	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Product Issues Device loosening	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Psychiatric disorders Psychotic disorder	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Psychiatric disorders Substance abuse	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 4/352 • Number of events 4 • From first dose up to week 124 As treated population	1.0% 11/1056 • Number of events 11 • From first dose up to week 124 As treated population	1.8% 10/554 • Number of events 11 • From first dose up to week 124 As treated population	0.76% 8/1052 • Number of events 9 • From first dose up to week 124 As treated population	0.69% 1/145 • Number of events 1 • From first dose up to week 124 As treated population	1.4% 2/139 • Number of events 3 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Rapidly progressive osteoarthritis	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.38% 4/1056 • Number of events 7 • From first dose up to week 124 As treated population	2.3% 13/554 • Number of events 13 • From first dose up to week 124 As treated population	4.2% 44/1052 • Number of events 53 • From first dose up to week 124 As treated population	0.69% 1/145 • Number of events 1 • From first dose up to week 124 As treated population	0.72% 1/139 • Number of events 1 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Osteoarthritis	0.85% 3/352 • Number of events 3 • From first dose up to week 124 As treated population	0.28% 3/1056 • Number of events 3 • From first dose up to week 124 As treated population	0.54% 3/554 • Number of events 3 • From first dose up to week 124 As treated population	0.57% 6/1052 • Number of events 6 • From first dose up to week 124 As treated population	0.69% 1/145 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.36% 2/554 • Number of events 2 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.72% 1/139 • Number of events 1 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.69% 1/145 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Exostosis	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Limb mass	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.72% 1/139 • Number of events 1 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Spinal synovial cyst	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Subchondral insufficiency fracture	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.69% 1/145 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations COVID-19 pneumonia	0.57% 2/352 • Number of events 2 • From first dose up to week 124 As treated population	0.28% 3/1056 • Number of events 3 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations COVID-19	0.00% 0/352 • From first dose up to week 124 As treated population	0.19% 2/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.36% 2/554 • Number of events 2 • From first dose up to week 124 As treated population	0.29% 3/1052 • Number of events 3 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Cellulitis	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.19% 2/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Gastroenteritis	0.00% 0/352 • From first dose up to week 124 As treated population	0.19% 2/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.36% 2/554 • Number of events 2 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.69% 1/145 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Sepsis	0.00% 0/352 • From first dose up to week 124 As treated population	0.19% 2/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Arthritis infective	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Diverticulitis	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Empyema	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Gastric ulcer helicobacter	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Infectious pleural effusion	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Peritonsillar abscess	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Pneumonia	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.29% 3/1052 • Number of events 3 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Pneumonia klebsiella	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Post procedural infection	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Urinary tract infection	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Appendicitis	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Erysipelas	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Escherichia urinary tract infection	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Infected bite	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Lower respiratory tract infection	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Lung abscess	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Meningitis	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Meningitis pneumococcal	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Pneumonia bacterial	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Post procedural cellulitis	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.69% 1/145 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Pyelonephritis	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Tuberculosis	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Infections and infestations Wound infection staphylococcal	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Surgical and medical procedures Knee arthroplasty	2.0% 7/352 • Number of events 7 • From first dose up to week 124 As treated population	0.66% 7/1056 • Number of events 7 • From first dose up to week 124 As treated population	0.72% 4/554 • Number of events 4 • From first dose up to week 124 As treated population	1.6% 17/1052 • Number of events 20 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Surgical and medical procedures Hip arthroplasty	0.00% 0/352 • From first dose up to week 124 As treated population	0.47% 5/1056 • Number of events 6 • From first dose up to week 124 As treated population	0.90% 5/554 • Number of events 5 • From first dose up to week 124 As treated population	0.29% 3/1052 • Number of events 3 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Surgical and medical procedures Joint arthroplasty	0.57% 2/352 • Number of events 2 • From first dose up to week 124 As treated population	0.28% 3/1056 • Number of events 3 • From first dose up to week 124 As treated population	0.72% 4/554 • Number of events 4 • From first dose up to week 124 As treated population	0.76% 8/1052 • Number of events 8 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.72% 1/139 • Number of events 1 • From first dose up to week 124 As treated population
Surgical and medical procedures Joint resurfacing surgery	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Surgical and medical procedures Knee operation	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Acute coronary syndrome	0.00% 0/352 • From first dose up to week 124 As treated population	0.19% 2/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Coronary artery disease	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.19% 2/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Myocardial infarction	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.19% 2/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.36% 2/554 • Number of events 3 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Atrial fibrillation	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Cardiovascular disorder	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Myocardial ischaemia	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Acute myocardial infarction	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Angina unstable	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.38% 4/1052 • Number of events 4 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Atrial tachycardia	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Cardiac arrest	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Cardiac failure	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Cardiac failure congestive	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.36% 2/554 • Number of events 2 • From first dose up to week 124 As treated population	0.29% 3/1052 • Number of events 3 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Cardiac tamponade	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Cardiac disorders Extrasystoles	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Hiatus hernia	0.00% 0/352 • From first dose up to week 124 As treated population	0.19% 2/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Abdominal hernia	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Diarrhoea	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Haemorrhoids	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Intestinal obstruction	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Nausea	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Oedematous pancreatitis	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Peptic ulcer	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Small intestinal obstruction	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 3 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Vomiting	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Abdominal pain	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Anal fissure	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Food poisoning	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Gastrointestinal inflammation	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Inguinal hernia	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Intestinal haemorrhage	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Intestinal perforation	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Pancreatitis acute	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Gastrointestinal disorders Volvulus of small bowel	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Hip fracture	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Joint dislocation	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Limb injury	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Radius fracture	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Ankle fracture	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Deep vein thrombosis postoperative	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Femur fracture	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Foot fracture	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Joint injury	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Ligament rupture	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Spinal compression fracture	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Spinal fracture	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Tendon injury	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.36% 2/554 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Osteosarcoma	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign soft tissue neoplasm	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal hamartoma	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Retroperitoneal neoplasm	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Carotid artery aneurysm	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Cerebrovascular accident	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.36% 2/554 • Number of events 2 • From first dose up to week 124 As treated population	0.48% 5/1052 • Number of events 5 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Guillain-Barre syndrome	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Ischaemic stroke	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Transient ischaemic attack	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Vascular encephalopathy	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Carpal tunnel syndrome	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Cerebral infarction	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Cerebrospinal fistula	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Hemiplegic migraine	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Lumbar radiculopathy	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Muscle tone disorder	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Myelopathy	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Radiculopathy	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Sciatica	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Nervous system disorders Syncope	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
General disorders Sudden death	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.28% 3/1056 • Number of events 3 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.29% 3/1052 • Number of events 3 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
General disorders Death	0.57% 2/352 • Number of events 2 • From first dose up to week 124 As treated population	0.19% 2/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
General disorders Adverse drug reaction	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
General disorders Chest pain	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
General disorders Oedema peripheral	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Blood and lymphatic system disorders Anaemia	0.57% 2/352 • Number of events 4 • From first dose up to week 124 As treated population	0.38% 4/1056 • Number of events 4 • From first dose up to week 124 As treated population	0.36% 2/554 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Hepatobiliary disorders Cholecystitis	0.00% 0/352 • From first dose up to week 124 As treated population	0.19% 2/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Hepatobiliary disorders Cholangitis	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Hepatobiliary disorders Hepatitis alcoholic	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Hepatobiliary disorders Bile duct stone	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Hepatobiliary disorders Cholangitis acute	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Hepatobiliary disorders Cholelithiasis	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.29% 3/1052 • Number of events 3 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Metabolism and nutrition disorders Dehydration	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Metabolism and nutrition disorders Hypoglycaemia	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Renal and urinary disorders Nephrolithiasis	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.19% 2/1056 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Renal and urinary disorders Acute kidney injury	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Renal and urinary disorders Bladder prolapse	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Renal and urinary disorders Diabetic nephropathy	0.28% 1/352 • Number of events 2 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Renal and urinary disorders Prerenal failure	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Renal and urinary disorders Renal failure	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Renal and urinary disorders Renal impairment	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Vascular disorders Aortic stenosis	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Vascular disorders Peripheral artery occlusion	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Vascular disorders Aortic dissection	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Vascular disorders Deep vein thrombosis	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.19% 2/1052 • Number of events 2 • From first dose up to week 124 As treated population	0.69% 1/145 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Vascular disorders Hypertension	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.29% 3/1052 • Number of events 3 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Vascular disorders Hypertensive urgency	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Eye disorders Cataract	0.00% 0/352 • From first dose up to week 124 As treated population	0.09% 1/1056 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Eye disorders Eyelid ptosis	0.28% 1/352 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Reproductive system and breast disorders Cervical polyp	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.00% 0/554 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.10% 1/1052 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population
Reproductive system and breast disorders Ovarian cyst	0.00% 0/352 • From first dose up to week 124 As treated population	0.00% 0/1056 • From first dose up to week 124 As treated population	0.18% 1/554 • Number of events 1 • From first dose up to week 124 As treated population	0.00% 0/1052 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.00% 0/139 • From first dose up to week 124 As treated population

Other adverse events

Other adverse events
Measure	Placebo n=352 participants at risk Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)	Naproxen n=1056 participants at risk Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID	Fasinumab 1mg Q8W n=554 participants at risk Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID	Fasinumab 1mg Q4W n=1052 participants at risk Fasinumab 1 mg SC Q4W and naproxen-matching placebo PO, BID	Fasinumab 3mg Q4W n=145 participants at risk Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID	Fasinumab 6mg Q8W n=139 participants at risk Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID
Musculoskeletal and connective tissue disorders Arthralgia	21.6% 76/352 • Number of events 117 • From first dose up to week 124 As treated population	22.0% 232/1056 • Number of events 357 • From first dose up to week 124 As treated population	27.4% 152/554 • Number of events 228 • From first dose up to week 124 As treated population	27.0% 284/1052 • Number of events 467 • From first dose up to week 124 As treated population	9.0% 13/145 • Number of events 16 • From first dose up to week 124 As treated population	21.6% 30/139 • Number of events 42 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Back pain	11.1% 39/352 • Number of events 51 • From first dose up to week 124 As treated population	11.1% 117/1056 • Number of events 160 • From first dose up to week 124 As treated population	15.0% 83/554 • Number of events 112 • From first dose up to week 124 As treated population	11.8% 124/1052 • Number of events 155 • From first dose up to week 124 As treated population	2.8% 4/145 • Number of events 5 • From first dose up to week 124 As treated population	2.9% 4/139 • Number of events 5 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 20/352 • Number of events 27 • From first dose up to week 124 As treated population	5.9% 62/1056 • Number of events 82 • From first dose up to week 124 As treated population	6.1% 34/554 • Number of events 41 • From first dose up to week 124 As treated population	6.2% 65/1052 • Number of events 88 • From first dose up to week 124 As treated population	1.4% 2/145 • Number of events 2 • From first dose up to week 124 As treated population	2.2% 3/139 • Number of events 4 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Osteoarthritis	5.1% 18/352 • Number of events 23 • From first dose up to week 124 As treated population	3.2% 34/1056 • Number of events 41 • From first dose up to week 124 As treated population	4.0% 22/554 • Number of events 29 • From first dose up to week 124 As treated population	4.5% 47/1052 • Number of events 57 • From first dose up to week 124 As treated population	0.69% 1/145 • Number of events 1 • From first dose up to week 124 As treated population	1.4% 2/139 • Number of events 3 • From first dose up to week 124 As treated population
Musculoskeletal and connective tissue disorders Rapidly progressive osteoarthritis	1.4% 5/352 • Number of events 6 • From first dose up to week 124 As treated population	2.6% 27/1056 • Number of events 28 • From first dose up to week 124 As treated population	6.9% 38/554 • Number of events 45 • From first dose up to week 124 As treated population	10.4% 109/1052 • Number of events 126 • From first dose up to week 124 As treated population	2.1% 3/145 • Number of events 3 • From first dose up to week 124 As treated population	5.8% 8/139 • Number of events 8 • From first dose up to week 124 As treated population
Infections and infestations Nasopharyngitis	8.0% 28/352 • Number of events 37 • From first dose up to week 124 As treated population	8.7% 92/1056 • Number of events 122 • From first dose up to week 124 As treated population	9.7% 54/554 • Number of events 64 • From first dose up to week 124 As treated population	9.0% 95/1052 • Number of events 125 • From first dose up to week 124 As treated population	3.4% 5/145 • Number of events 5 • From first dose up to week 124 As treated population	1.4% 2/139 • Number of events 3 • From first dose up to week 124 As treated population
Infections and infestations Upper respiratory tract infection	7.1% 25/352 • Number of events 27 • From first dose up to week 124 As treated population	8.5% 90/1056 • Number of events 106 • From first dose up to week 124 As treated population	7.4% 41/554 • Number of events 51 • From first dose up to week 124 As treated population	8.7% 92/1052 • Number of events 111 • From first dose up to week 124 As treated population	3.4% 5/145 • Number of events 5 • From first dose up to week 124 As treated population	4.3% 6/139 • Number of events 6 • From first dose up to week 124 As treated population
Infections and infestations Urinary tract infection	6.8% 24/352 • Number of events 29 • From first dose up to week 124 As treated population	8.1% 86/1056 • Number of events 105 • From first dose up to week 124 As treated population	7.4% 41/554 • Number of events 45 • From first dose up to week 124 As treated population	7.5% 79/1052 • Number of events 101 • From first dose up to week 124 As treated population	2.8% 4/145 • Number of events 4 • From first dose up to week 124 As treated population	3.6% 5/139 • Number of events 5 • From first dose up to week 124 As treated population
Infections and infestations Influenza	6.8% 24/352 • Number of events 30 • From first dose up to week 124 As treated population	5.2% 55/1056 • Number of events 70 • From first dose up to week 124 As treated population	5.6% 31/554 • Number of events 41 • From first dose up to week 124 As treated population	6.7% 70/1052 • Number of events 85 • From first dose up to week 124 As treated population	0.69% 1/145 • Number of events 1 • From first dose up to week 124 As treated population	1.4% 2/139 • Number of events 2 • From first dose up to week 124 As treated population
Infections and infestations Bronchitis	5.4% 19/352 • Number of events 20 • From first dose up to week 124 As treated population	4.7% 50/1056 • Number of events 61 • From first dose up to week 124 As treated population	5.4% 30/554 • Number of events 34 • From first dose up to week 124 As treated population	3.9% 41/1052 • Number of events 46 • From first dose up to week 124 As treated population	0.69% 1/145 • Number of events 1 • From first dose up to week 124 As treated population	0.72% 1/139 • Number of events 1 • From first dose up to week 124 As treated population
Nervous system disorders Headache	19.0% 67/352 • Number of events 109 • From first dose up to week 124 As treated population	20.5% 216/1056 • Number of events 548 • From first dose up to week 124 As treated population	22.9% 127/554 • Number of events 308 • From first dose up to week 124 As treated population	22.4% 236/1052 • Number of events 588 • From first dose up to week 124 As treated population	9.0% 13/145 • Number of events 21 • From first dose up to week 124 As treated population	5.8% 8/139 • Number of events 10 • From first dose up to week 124 As treated population
Nervous system disorders Carpal tunnel syndrome	4.3% 15/352 • Number of events 16 • From first dose up to week 124 As treated population	1.9% 20/1056 • Number of events 23 • From first dose up to week 124 As treated population	4.7% 26/554 • Number of events 32 • From first dose up to week 124 As treated population	5.5% 58/1052 • Number of events 69 • From first dose up to week 124 As treated population	2.8% 4/145 • Number of events 6 • From first dose up to week 124 As treated population	3.6% 5/139 • Number of events 5 • From first dose up to week 124 As treated population
Gastrointestinal disorders Constipation	2.3% 8/352 • Number of events 8 • From first dose up to week 124 As treated population	6.2% 65/1056 • Number of events 75 • From first dose up to week 124 As treated population	2.2% 12/554 • Number of events 12 • From first dose up to week 124 As treated population	2.1% 22/1052 • Number of events 23 • From first dose up to week 124 As treated population	1.4% 2/145 • Number of events 2 • From first dose up to week 124 As treated population	1.4% 2/139 • Number of events 2 • From first dose up to week 124 As treated population
Gastrointestinal disorders Gastritis	3.4% 12/352 • Number of events 12 • From first dose up to week 124 As treated population	5.1% 54/1056 • Number of events 72 • From first dose up to week 124 As treated population	4.9% 27/554 • Number of events 35 • From first dose up to week 124 As treated population	3.1% 33/1052 • Number of events 41 • From first dose up to week 124 As treated population	0.00% 0/145 • From first dose up to week 124 As treated population	0.72% 1/139 • Number of events 1 • From first dose up to week 124 As treated population
Vascular disorders Hypertension	8.8% 31/352 • Number of events 34 • From first dose up to week 124 As treated population	7.3% 77/1056 • Number of events 88 • From first dose up to week 124 As treated population	6.5% 36/554 • Number of events 41 • From first dose up to week 124 As treated population	5.2% 55/1052 • Number of events 59 • From first dose up to week 124 As treated population	1.4% 2/145 • Number of events 2 • From first dose up to week 124 As treated population	0.72% 1/139 • Number of events 1 • From first dose up to week 124 As treated population

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