Trial Outcomes & Findings for A Study of Ixekizumab in Participants With Active Psoriatic Arthritis (NCT NCT01695239)

Last Updated: 2019-01-08

Results Overview

ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

417 participants

Primary outcome timeframe

Week 24

Results posted on

2019-01-08

Participant Flow

The Double-Blind Treatment Period was Week 0 up to Week 24 (Inadequate responders (IR) Week 16-24) followed by the combined extension period and long-term extension period from Week 24 to Week 156.

Participant milestones

Participant milestones
Measure	Placebo (PBO) Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.	Adalimumab (ADA) Q2W Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixe Q4W Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixe Q2W Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Inadequate Responders (IR)/Ixe Q4W Placebo Week 16 inadequate responders (IRs) re-randomized to ixekizumab 80 mg every 4 weeks (Q4W) received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab Q4W IRs received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy.	IR/Ixe Q2W Placebo IRs re-randomized to ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 16. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy. Ixekizumab 80 mg Q2W IRs received one SC injection of 80 mg of ixekizumab Q2W from Week 18 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 18 to Week 24. Participants also received rescue therapy.	IR PBO Washout Adalimumab Q2W IRs re-randomized to ixekizumab 80 mg Q4W or ixekizumab 80 mg Q2W. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 16. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 18 to Week 22. Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24.	PBO Washout Adalimumab Q2W participants re-randomized to ixekizumab 80 mg Q4W or ixekizumab Q2W Week 24. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 24. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 26 to Week 30. Participants received a dose of 80 mg of ixekizumab given as 1 SC injection at Week 32.	Ixe Q4W/Ixe Q4W Participants continuing on 1 injection of ixekizumab 80 mg Q4W starting on Week 24 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 28 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 32 and ending on Week 156 alternating with placebo injections Q4W starting on Week 34 and ending on Week 154.	Ixe Q2W/Ixe Q2W Participants continuing on 1 injection of ixekizumab 80 mg Q2W starting on Week 24 and ending on Week 156. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg Q2W at Week 16 and Week 24. Placebo washout participants who re-randomized at Week 16 receive a starting dose of 160 mg ixekizumab given as 2 SC injections of 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 28 and ending on Week 156. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 32 and ending on Week 156.	Placebo Post-Treatment Follow-up Period Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.	Adalimumab Post-Treatment Follow-up Period Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.	Ixekizumab 80mg Q4W Post-Treatment Follow-up Period Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.	Ixekizumab 80mg Q2W Post-Treatment Follow-up Period Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
Double-Blind (DB) Treatment Period STARTED	106	101	107	103	0	0	0	0	0	0	0	0	0	0
Double-Blind (DB) Treatment Period Received at Least 1 Dose of Study Drug	106	101	107	102	0	0	0	0	0	0	0	0	0	0
Double-Blind (DB) Treatment Period Classified as Inadequate Responder (IR)	27	9	11	10	0	0	0	0	0	0	0	0	0	0
Double-Blind (DB) Treatment Period COMPLETED	91	97	97	96	0	0	0	0	0	0	0	0	0	0
Double-Blind (DB) Treatment Period NOT COMPLETED	15	4	10	7	0	0	0	0	0	0	0	0	0	0
IR Participants (Week 16 Up To Week 24) STARTED	0	0	0	0	24	24	9	0	0	0	0	0	0	0
IR Participants (Week 16 Up To Week 24) COMPLETED	0	0	0	0	24	24	9	0	0	0	0	0	0	0
IR Participants (Week 16 Up To Week 24) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Placebo Washout (Week 24 Up To Week 32) STARTED	0	0	0	0	0	0	0	88	0	0	0	0	0	0
Placebo Washout (Week 24 Up To Week 32) COMPLETED	0	0	0	0	0	0	0	77	0	0	0	0	0	0
Placebo Washout (Week 24 Up To Week 32) NOT COMPLETED	0	0	0	0	0	0	0	11	0	0	0	0	0	0
Extension Long-Term Extension Periods STARTED	0	0	0	0	0	0	0	0	187	183	0	0	0	0
Extension Long-Term Extension Periods COMPLETED	0	0	0	0	0	0	0	0	121	122	0	0	0	0
Extension Long-Term Extension Periods NOT COMPLETED	0	0	0	0	0	0	0	0	66	61	0	0	0	0
Post-Treatment Follow-Up Period STARTED	0	0	0	0	0	0	0	0	0	0	20	1	165	171
Post-Treatment Follow-Up Period COMPLETED	0	0	0	0	0	0	0	0	0	0	20	0	156	166
Post-Treatment Follow-Up Period NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	1	9	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo (PBO) Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.	Adalimumab (ADA) Q2W Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixe Q4W Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixe Q2W Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	PBO Washout Adalimumab Q2W participants re-randomized to ixekizumab 80 mg Q4W or ixekizumab Q2W Week 24. Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 24. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 26 to Week 30. Participants received a dose of 80 mg of ixekizumab given as 1 SC injection at Week 32.	Ixe Q4W/Ixe Q4W Participants continuing on 1 injection of ixekizumab 80 mg Q4W starting on Week 24 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 28 and ending on Week 156 alternating with placebo injections Q4W starting on Week 26 and ending on Week 154. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q4W starting on Week 32 and ending on Week 156 alternating with placebo injections Q4W starting on Week 34 and ending on Week 154.	Ixe Q2W/Ixe Q2W Participants continuing on 1 injection of ixekizumab 80 mg Q2W starting on Week 24 and ending on Week 156. Additionally, includes placebo washout participants who were re-randomized to ixekizumab 80 mg Q2W at Week 16 and Week 24. Placebo washout participants who re-randomized at Week 16 receive a starting dose of 160 mg ixekizumab given as 2 SC injections of 80 mg given at Week 24 followed by 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 28 and ending on Week 156. Placebo washout participants who re-randomized at Week 24 receive 1 SC injection of 80 mg of ixekizumab Q2W starting on Week 32 and ending on Week 156.	Adalimumab Post-Treatment Follow-up Period Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.	Ixekizumab 80mg Q4W Post-Treatment Follow-up Period Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.	Ixekizumab 80mg Q2W Post-Treatment Follow-up Period Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
Double-Blind (DB) Treatment Period Entry Criteria Not Met	1	1	3	4	0	0	0	0	0	0
Double-Blind (DB) Treatment Period Adverse Event	2	2	2	3	0	0	0	0	0	0
Double-Blind (DB) Treatment Period Lack of Efficacy	4	0	2	0	0	0	0	0	0	0
Double-Blind (DB) Treatment Period Withdrawal by Subject	3	1	1	0	0	0	0	0	0	0
Double-Blind (DB) Treatment Period Sponsor Decision	3	0	1	0	0	0	0	0	0	0
Double-Blind (DB) Treatment Period Lost to Follow-up	1	0	1	0	0	0	0	0	0	0
Double-Blind (DB) Treatment Period Protocol Violation	1	0	0	0	0	0	0	0	0	0
Placebo Washout (Week 24 Up To Week 32) Lack of Efficacy	0	0	0	0	9	0	0	0	0	0
Placebo Washout (Week 24 Up To Week 32) Adverse Event	0	0	0	0	1	0	0	0	0	0
Placebo Washout (Week 24 Up To Week 32) Entry Criteria Not Met	0	0	0	0	1	0	0	0	0	0
Extension Long-Term Extension Periods Lack of Efficacy	0	0	0	0	0	37	31	0	0	0
Extension Long-Term Extension Periods Adverse Event	0	0	0	0	0	15	21	0	0	0
Extension Long-Term Extension Periods Withdrawal by Subject	0	0	0	0	0	6	7	0	0	0
Extension Long-Term Extension Periods Physician Decision	0	0	0	0	0	3	0	0	0	0
Extension Long-Term Extension Periods Lost to Follow-up	0	0	0	0	0	2	1	0	0	0
Extension Long-Term Extension Periods Sponsor Decision	0	0	0	0	0	2	1	0	0	0
Extension Long-Term Extension Periods Death	0	0	0	0	0	1	0	0	0	0
Post-Treatment Follow-Up Period Withdrawal by Subject	0	0	0	0	0	0	0	1	6	3
Post-Treatment Follow-Up Period Lost to Follow-up	0	0	0	0	0	0	0	0	1	1
Post-Treatment Follow-Up Period Physician Decision	0	0	0	0	0	0	0	0	2	0
Post-Treatment Follow-Up Period Protocol Violation	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=106 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	ADA Q2W n=101 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixe Q4W n=107 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixe Q2W n=103 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Total n=417 Participants Total of all reporting groups
Region of Enrollment Spain	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants
Region of Enrollment Canada	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment Czechia	22 Participants n=5 Participants	25 Participants n=7 Participants	23 Participants n=5 Participants	22 Participants n=4 Participants	92 Participants n=21 Participants
Age, Continuous	50.60 years STANDARD_DEVIATION 12.32 • n=5 Participants	48.58 years STANDARD_DEVIATION 12.43 • n=7 Participants	49.07 years STANDARD_DEVIATION 10.07 • n=5 Participants	49.79 years STANDARD_DEVIATION 12.62 • n=4 Participants	49.52 years STANDARD_DEVIATION 11.87 • n=21 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	50 Participants n=7 Participants	62 Participants n=5 Participants	55 Participants n=4 Participants	225 Participants n=21 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	51 Participants n=7 Participants	45 Participants n=5 Participants	48 Participants n=4 Participants	192 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	15 Participants n=21 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
Race (NIH/OMB) Black or African American	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
Race (NIH/OMB) White	99 Participants n=5 Participants	95 Participants n=7 Participants	102 Participants n=5 Participants	96 Participants n=4 Participants	392 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	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
Race/Ethnicity, Customized Hispanic or Latino	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	20 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	92 Participants n=5 Participants	83 Participants n=7 Participants	94 Participants n=5 Participants	87 Participants n=4 Participants	356 Participants n=21 Participants
Race/Ethnicity, Customized Unknown or Not Reported	8 Participants n=5 Participants	13 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	41 Participants n=21 Participants
Region of Enrollment Russia	9 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	34 Participants n=21 Participants
Region of Enrollment United States	22 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	20 Participants n=4 Participants	83 Participants n=21 Participants
Region of Enrollment Japan	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Region of Enrollment Ukraine	9 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	35 Participants n=21 Participants
Region of Enrollment United Kingdom	3 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	17 Participants n=21 Participants
Region of Enrollment Netherlands	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Belgium	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment Poland	16 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	60 Participants n=21 Participants
Region of Enrollment Mexico	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Region of Enrollment France	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment Bulgaria	3 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Region of Enrollment Estonia	6 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	29 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 24

Population: All randomized participants. Nonresponder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=101 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=107 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=103 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])	30.2 percentage of participants	57.4 percentage of participants	57.9 percentage of participants	62.1 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=101 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=107 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=103 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Percentage of Participants Achieving ACR20 Response	31.1 percentage of participants	51.5 percentage of participants	57.0 percentage of participants	60.2 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=101 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=107 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=103 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response	15.1 percentage of participants	38.6 percentage of participants	40.2 percentage of participants	46.6 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=101 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=107 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=103 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score	5.7 percentage of participants	25.7 percentage of participants	23.4 percentage of participants	34.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post baseline HAQ-DI data.

HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=105 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=97 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=103 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=98 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])	-0.1797 units on a scale Standard Error 0.0524	-0.3712 units on a scale Standard Error 0.0510	-0.4431 units on a scale Standard Error 0.0503	-0.4963 units on a scale Standard Error 0.0507

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post baseline mTSS data.

The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=101 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=107 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=103 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])	0.49 units on a scale Standard Error 0.086	0.10 units on a scale Standard Error 0.085	0.17 units on a scale Standard Error 0.082	0.08 units on a scale Standard Error 0.083

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=68 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=73 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=59 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100) PASI 75	7.5 percentage of participants	33.8 percentage of participants	75.3 percentage of participants	69.5 percentage of participants
Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100) PASI 90	1.5 percentage of participants	22.1 percentage of participants	52.1 percentage of participants	57.6 percentage of participants
Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100) PASI 100	1.5 percentage of participants	14.7 percentage of participants	31.5 percentage of participants	40.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.

The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=55 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=70 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=56 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Leeds Enthesitis Index (LEI)	-0.8 units on a scale Standard Error 0.24	-0.8 units on a scale Standard Error 0.24	-0.9 units on a scale Standard Error 0.21	-1.5 units on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants who had baseline psoriatic lesion(s) involving \>=3% BSA, baseline itch NRS score and post baseline itch NRS score.

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=68 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=73 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=59 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])	0.2 units on a scale Standard Error 0.27	-1.4 units on a scale Standard Error 0.28	-2.6 units on a scale Standard Error 0.27	-2.8 units on a scale Standard Error 0.30

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline and post baseline fatigue NRS data.

The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=97 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=101 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=97 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])	-1.3 units on a scale Standard Error 0.25	-1.5 units on a scale Standard Error 0.24	-1.6 units on a scale Standard Error 0.24	-1.9 units on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline and post baseline JSN data. All randomized participants who had baseline and post baseline BES data. Linear extrapolation was used to impute missing data.

JSN score (a component of the modified Total Sharp Score \[mTSS\]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the \[mTSS\]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.

Outcome measures

Outcome measures
Measure	Placebo n=91 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=95 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=97 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=96 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES) Joint Space Narrowing Score	0.07 units on a scale Standard Error 0.031	0.01 units on a scale Standard Error 0.031	0.04 units on a scale Standard Error 0.030	0.01 units on a scale Standard Error 0.030
Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES) Bone Erosion Score	0.44 units on a scale Standard Error 0.077	0.12 units on a scale Standard Error 0.077	0.15 units on a scale Standard Error 0.075	0.08 units on a scale Standard Error 0.075

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline and post baseline PCS data. All randomized participants who had baseline and post baseline MCS data.

SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score \[PCS\] and mental component score \[MCS\]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=99 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=95 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=98 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=95 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO]) PCS Score	2.94 units on a scale Standard Error 0.958	6.78 units on a scale Standard Error 0.904	7.45 units on a scale Standard Error 0.894	8.24 units on a scale Standard Error 0.898
Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO]) MCS Score	2.67 units on a scale Standard Error 1.013	4.22 units on a scale Standard Error 0.943	4.86 units on a scale Standard Error 0.933	3.39 units on a scale Standard Error 0.936

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline and post baseline QIDS-SR16 data.

The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=101 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=98 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=102 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=99 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])	-0.9 units on a scale Standard Error 0.36	-1.6 units on a scale Standard Error 0.33	-0.8 units on a scale Standard Error 0.32	-0.7 units on a scale Standard Error 0.32

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline and post baseline DAS28-CRP data.

The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP measured in milligram/liter (mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.

Outcome measures

Outcome measures
Measure	Placebo n=104 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=99 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=106 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=99 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease	-0.835 units on a scale Standard Error 0.1307	-1.743 units on a scale Standard Error 0.1215	-1.955 units on a scale Standard Error 0.1206	-2.036 units on a scale Standard Error 0.1225

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=101 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=107 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=103 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)	32.1 percentage of participants	58.4 percentage of participants	57.9 percentage of participants	66.0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.

The sPGA is the physician's determination of the severity of the participant's psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=37 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=52 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=41 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline	17.1 percentage of participants	62.2 percentage of participants	65.4 percentage of participants	73.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who have plaque psoriasis at baseline and who had baseline and post baseline BSA data.

The investigator evaluated the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=99 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=94 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=100 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=91 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Percent Change From Baseline in Body Surface Area (BSA)	-2.7 percent change in BSA Standard Error 1.36	-9.5 percent change in BSA Standard Error 1.35	-12.0 percent change in BSA Standard Error 1.32	-10.6 percent change in BSA Standard Error 1.39

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline fingernail involvement, baseline NAPSI score and post baseline NAPSI score.

The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=69 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=68 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=66 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=69 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline	-2.4 units on a scale Standard Error 1.66	-10.7 units on a scale Standard Error 1.49	-14.0 units on a scale Standard Error 1.54	-15.5 units on a scale Standard Error 1.49

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline dactylitis, baseline LDI-B score and post baseline LDI-B score.

The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference over the contra-lateral digit. If the same digits on each hand or foot were thought to be involved, the clinician referred to a table of normative values for a value which was used to provide the comparison. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=39 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=23 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=54 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=41 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)	-25.4 units on a scale Standard Error 6.53	-57.1 units on a scale Standard Error 7.84	-57.1 units on a scale Standard Error 5.67	-48.3 units on a scale Standard Error 6.31

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline axial involvement defined as baseline BASDAI score \>4, baseline BASDAI score and post baseline BASDAI score.

The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=73 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=85 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=71 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-1.25 units on a scale Standard Error 0.268	-2.42 units on a scale Standard Error 0.249	-2.74 units on a scale Standard Error 0.234	-2.91 units on a scale Standard Error 0.251

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: All randomized participants who received at least 1 dose of ixe and had evaluable anti-ixekizumab antibody measurement at baseline and post baseline or had no evaluable baseline anti-ixekizumab antibody measurements. Immunogenicity data was not collected during the double-blind treatment period for participants in the adalimumab treatment group.

Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.

Outcome measures

Outcome measures
Measure	Placebo n=103 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=107 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=100 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb) Treatment Emergent (TE)	0 participants	6 participants	5 participants	—
Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb) NAb	0 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: All randomized participants with post-baseline ACR data.

The ACR-N score is a continuous measure of clinical, laboratory, and functional outcomes that characterizes the percentage of improvement from baseline in disease activity and the lowest of either a) the percent change in tender joint count (TJC) b) the percent change in swollen joint count (SJC), or c) the median percent change of the remaining 5 ACR core criteria. An ACR-N score of X has improvement of at least X% in both TJC and SJC and a median improvement of at least X% in 5 criteria: patient's assessment of arthritis pain, PatGA, PGA, HAQ-DI and hs-CRP. ACR-N is calculated by allowing for negative results which indicate worsening. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=101 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=107 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=103 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Percent Change in American College of Rheumatology-N (ACR-N) Score	-4.182 percent change Standard Error 6.1417	28.517 percent change Standard Error 5.9189	33.509 percent change Standard Error 5.8905	30.391 percent change Standard Error 5.9736

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post-baseline TJC data.

TJC is calculated based on tenderness response of 68 joints. TJC possible values range from 0 to 68. A lower TJC indicated less joint tenderness. A higher TJC indicated more joint tenderness. TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=100 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=107 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=102 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Tender Joint Counts (TJC)	-4.7 joint counts Standard Error 1.14	-10.1 joint counts Standard Error 1.10	-11.9 joint counts Standard Error 1.08	-13.6 joint counts Standard Error 1.09

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post-baseline SJC data.

SJC is calculated based on swelling response of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joint swelling. A higher SJC indicated more joint swelling. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=100 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=107 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=102 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Swollen Joint Counts (SJC)	-3.5 joint counts Standard Error 0.62	-6.1 joint counts Standard Error 0.59	-7.0 joint counts Standard Error 0.59	-8.3 joint counts Standard Error 0.59

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post-baseline patient's assessment of pain data.

The VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, participants scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=105 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=99 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=104 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=98 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Patient's Assessment of Pain VAS	-14.0 units on a scale Standard Error 2.68	-30.0 units on a scale Standard Error 2.52	-29.6 units on a scale Standard Error 2.51	-31.6 units on a scale Standard Error 2.54

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post-baseline patient's global assessment of disease activity data.

Participants scored their overall assessment of their PsA activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=105 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=99 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=104 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=98 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) VAS	-14.8 units on a scale Standard Error 2.65	-31.6 units on a scale Standard Error 2.49	-33.8 units on a scale Standard Error 2.48	-35.6 units on a scale Standard Error 2.50

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: All randomized participants with baseline and post-baseline physician's global assessment of disease activity data.

The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 0 to 100 mm horizontal VAS. The scale ranged from 0 no disease activity to 100 extremely active disease activity. The scores were measured to the nearest millimeter from the left. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=100 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=88 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=96 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=95 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Physician's Global Assessment of Disease Activity VAS	-24.2 units on a scale Standard Error 2.14	-34.7 units on a scale Standard Error 2.10	-38.5 units on a scale Standard Error 2.06	-42.0 units on a scale Standard Error 1.99

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants with baseline and post-baseline CRP data.

CRP milligram/liter (mg/L) was measured with a high sensitivity assay at a central laboratory to assess acute phase reactant. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.

Outcome measures

Outcome measures
Measure	Placebo n=106 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=101 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=107 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=103 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in C-Reactive Protein (CRP)	-3.873 milligram/liter (mg/L) Standard Error 1.4292	-7.512 milligram/liter (mg/L) Standard Error 1.2674	-8.804 milligram/liter (mg/L) Standard Error 1.2602	-8.942 milligram/liter (mg/L) Standard Error 1.2552

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.

Outcome measures

Outcome measures
Measure	Placebo n=57 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=56 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=70 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=59 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Leeds Enthesitis Index (LEI)	-0.8 units on a scale Standard Error 0.26	-0.9 units on a scale Standard Error 0.23	-1.3 units on a scale Standard Error 0.21	-1.4 units on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: Week 24

Outcome measures

Outcome measures
Measure	Placebo n=38 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=61 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=60 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=49 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100) PASI 75	10.9 percentage of participants	55.2 percentage of participants	71.2 percentage of participants	80.4 percentage of participants
Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100) PASI 90	6.3 percentage of participants	37.3 percentage of participants	56.2 percentage of participants	67.9 percentage of participants
Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100) PASI 100	3.1 percentage of participants	23.9 percentage of participants	42.5 percentage of participants	53.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who had baseline psoriatic lesion(s) involving \>=3% BSA, baseline itch NRS score and post baseline itch NRS score.

Outcome measures

Outcome measures
Measure	Placebo n=67 Participants Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	Adalimumab Q2W n=68 Participants Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	Ixekizumab Q4W n=73 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixekizumab Q2W n=59 Participants Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Change From Baseline in Itching Severity Using the Itch NRS	-0.3 units on a scale Standard Error 0.32	-1.7 units on a scale Standard Error 0.29	-2.9 units on a scale Standard Error 0.29	-2.8 units on a scale Standard Error 0.31

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (PBO) Double-Blind Period n=106 participants at risk Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.	Adalimumab (ADA) Double-Blind Period n=101 participants at risk Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24	Ixe Q2W Double-Blind Period n=107 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixe Q4W Double-Blind Period n=102 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W or Placebo for ixekizumab (ixe) Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	IR IXE Q4W n=24 participants at risk Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	IR IXE Q2W n=24 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	IR PBO Washout n=9 participants at risk Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	PBO Washout n=88 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	IXE Q4W n=187 participants at risk Ixekizumab every 4 weeks (IxeQ4W) and IR IxeQ4W participants received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 24 to Week 156. Placebo and IR placebo (PBO) Washout participants re-randomized to Ixekizumab 80 mg Q4W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of alternating placebo for ixekizumab or ixekizumab Q2W from Week 26 to Week 156. PBO Washout participants re-randomized to ixekizumab 80 mg Q4W received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 32 to Week 156.	IXE Q2W n=183 participants at risk Ixekizumab Q2W (IxeQ2W) and IR IxeQ2W participants received one SC injection of 80 mg of ixekizumab Q2W from Week 24 to Week 156. Placebo and IR PBO Washout participants re-randomized to Ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 26 to Week 156. PBO Washout participants re-randomized to ixekizumab 80 mg Q2W received one SC injection of 80 mg of ixekizumab Q2W from Week 32 to Week 156.	PBO Post-Treatment Follow-Up Period n=20 participants at risk Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.	Adalimumab Post-Treatment Follow-up Period n=1 participants at risk Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.	IXE Q4W Post-Treatment Follow-up Period n=165 participants at risk Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.	IXE Q2W Post-Treatment Follow-up Period n=171 participants at risk Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 3 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Ligament injury	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.98% 1/102 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.93% 1/107 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Cardiac disorders Acute myocardial infarction	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Cardiac disorders Cardiac disorder	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Cardiac disorders Coronary artery disease	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	1.1% 2/183 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Cardiac disorders Coronary artery occlusion	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Cardiac disorders Myocardial ischaemia	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Eye disorders Retinal detachment	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 5 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Duodenitis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.58% 1/171 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophagitis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.93% 1/107 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	1.1% 2/187 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.93% 1/107 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Immune system disorders Anaphylactic reaction	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.61% 1/165 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Arthritis bacterial	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Cellulitis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Chronic tonsillitis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.93% 1/107 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis clostridial	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Herpes zoster	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.98% 1/102 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Latent tuberculosis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Oesophageal candidiasis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.98% 1/102 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	1.1% 2/187 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Pneumonia mycoplasmal	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Anastomotic stenosis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Limb injury	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Perirenal haematoma	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Investigations Hepatic enzyme increased	0.94% 1/106 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Metabolism and nutrition disorders Obesity	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.93% 1/107 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.61% 1/165 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acoustic neuroma	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine benign neoplasm	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/48 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/51 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/45 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/47 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/8 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/8 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/50 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/78 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/92 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/10 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/71 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	1.1% 1/87 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Nervous system disorders Carotid artery occlusion	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.99% 1/101 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Nervous system disorders Carotid artery stenosis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Nervous system disorders Cervical myelopathy	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.98% 1/102 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Nervous system disorders Depressed level of consciousness	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Nervous system disorders Guillain-barre syndrome	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Nervous system disorders Ischaemic stroke	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Nervous system disorders Post-traumatic headache	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.93% 1/107 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Nervous system disorders Sciatica	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Nervous system disorders Transient ischaemic attack	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Psychiatric disorders Confusional state	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Reproductive system and breast disorders Acquired phimosis	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.98% 1/102 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Reproductive system and breast disorders Bartholin's cyst	1.7% 1/58 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/50 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/62 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/55 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/16 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/16 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/8 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/38 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/109 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/91 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/10 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/94 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/84 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/58 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.0% 1/50 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/62 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/55 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/16 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/16 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/8 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/38 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/109 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/91 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/10 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/94 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/84 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Reproductive system and breast disorders Uterine polyp	0.00% 0/58 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/50 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	1.6% 1/62 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/55 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/16 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/16 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/8 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/38 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/109 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/91 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/10 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/94 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/84 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Reproductive system and breast disorders Vulval disorder	0.00% 0/58 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/50 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/62 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/55 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/16 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/16 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/8 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/38 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.92% 1/109 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/91 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/10 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/94 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/84 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Surgical and medical procedures Hip arthroplasty	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.53% 1/187 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/183 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Vascular disorders Hypertension	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/107 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/102 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	1.1% 1/88 • Number of events 3 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/187 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.55% 1/183 • Number of events 4 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Placebo (PBO) Double-Blind Period n=106 participants at risk Participants received placebo for ixekizumab (ixe) as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.	Adalimumab (ADA) Double-Blind Period n=101 participants at risk Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24	Ixe Q2W Double-Blind Period n=107 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	Ixe Q4W Double-Blind Period n=102 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W or Placebo for ixekizumab (ixe) Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	IR IXE Q4W n=24 participants at risk Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.	IR IXE Q2W n=24 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	IR PBO Washout n=9 participants at risk Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.	PBO Washout n=88 participants at risk Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.	IXE Q4W n=187 participants at risk Ixekizumab every 4 weeks (IxeQ4W) and IR IxeQ4W participants received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 24 to Week 156. Placebo and IR placebo (PBO) Washout participants re-randomized to Ixekizumab 80 mg Q4W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of alternating placebo for ixekizumab or ixekizumab Q2W from Week 26 to Week 156. PBO Washout participants re-randomized to ixekizumab 80 mg Q4W received one SC injection of 80 mg of alternating ixekizumab or placebo for ixekizumab Q2W from Week 32 to Week 156.	IXE Q2W n=183 participants at risk Ixekizumab Q2W (IxeQ2W) and IR IxeQ2W participants received one SC injection of 80 mg of ixekizumab Q2W from Week 24 to Week 156. Placebo and IR PBO Washout participants re-randomized to Ixekizumab 80 mg Q2W received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 24. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 26 to Week 156. PBO Washout participants re-randomized to ixekizumab 80 mg Q2W received one SC injection of 80 mg of ixekizumab Q2W from Week 32 to Week 156.	PBO Post-Treatment Follow-Up Period n=20 participants at risk Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.	Adalimumab Post-Treatment Follow-up Period n=1 participants at risk Participants discontinued the study early and entered the post-treatment follow-up period. Participants received adalimumab Q2W immediately prior to entering the post-treatment follow-up period.	IXE Q4W Post-Treatment Follow-up Period n=165 participants at risk Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.	IXE Q2W Post-Treatment Follow-up Period n=171 participants at risk Participants either completed the study or discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
General disorders Injection site erythema	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.0% 2/101 • Number of events 5 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	6.5% 7/107 • Number of events 11 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	12.7% 13/102 • Number of events 42 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	1.6% 3/187 • Number of events 6 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.7% 5/183 • Number of events 51 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
General disorders Injection site reaction	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 5 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	12.1% 13/107 • Number of events 31 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	15.7% 16/102 • Number of events 63 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	6.4% 12/187 • Number of events 63 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	7.1% 13/183 • Number of events 180 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Bronchitis	2.8% 3/106 • Number of events 3 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	4.0% 4/101 • Number of events 5 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.8% 3/107 • Number of events 3 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.9% 3/102 • Number of events 4 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	5.3% 10/187 • Number of events 13 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	5.5% 10/183 • Number of events 11 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Pharyngitis	0.94% 1/106 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/101 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.93% 1/107 • Number of events 1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.0% 2/102 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.3% 2/88 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.7% 5/187 • Number of events 7 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	6.6% 12/183 • Number of events 14 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	6.6% 7/106 • Number of events 7 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	5.0% 5/101 • Number of events 5 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	4.7% 5/107 • Number of events 5 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.9% 3/102 • Number of events 4 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.3% 2/88 • Number of events 3 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	11.2% 21/187 • Number of events 27 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	9.8% 18/183 • Number of events 23 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Infections and infestations Viral upper respiratory tract infection	4.7% 5/106 • Number of events 6 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	5.9% 6/101 • Number of events 7 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	5.6% 6/107 • Number of events 6 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.0% 2/102 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	3.4% 3/88 • Number of events 3 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	11.2% 21/187 • Number of events 32 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	11.5% 21/183 • Number of events 23 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/106 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	3.0% 3/101 • Number of events 3 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	1.9% 2/107 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	2.0% 2/102 • Number of events 2 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/24 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/9 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/88 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	5.9% 11/187 • Number of events 11 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	3.3% 6/183 • Number of events 6 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/20 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/1 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/165 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.	0.00% 0/171 Adverse events were summarized based on all randomized participants who received at least one dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60