Trial Outcomes & Findings for A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (NCT NCT03926130)

Last Updated: 2024-12-27

Results Overview

Clinical response by patient reported outcome (PRO) defined as ≥30% decrease in stool frequency (SF) and/or abdominal pain (AP) \& neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Endoscopic response defined as ≥50% reduction from baseline in total Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence \& size of ulcers (none=0; diameter 0.1-0.5 cm=1; 0.5-2 cm=2; \>2 cm=3); extent of ulcerated surface (none=0; \<10%=1; 10% to 30%=2; \>30%=3); extent of affected surface (none=0; \<50%=1; 50% to 75%=2; \>75%=3); presence \& type of narrowing (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1158 participants

Primary outcome timeframe

Week 12 to Week 52

Results posted on

2024-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received Placebo intravenously (IV) or subcutaneously (SC) every 4 weeks (Q4W). Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 milligrams (mg) Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. Nonresponse is defined as failing to achieve at least a 30% decrease in stool frequency (SF) and/or abdominal pain (AP) and be no worse than baseline.	Mirikizumab Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 milligrams per kilogram (mg/kg) Ustekinumab IV for one dose, then 90 mg SC every 8 weeks (Q8W)	Mirikizumab (Adolescents) Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W
Overall Study STARTED	212	631	309	6
Overall Study Received at Least One Dose of Study Drug	211	630	309	6
Overall Study Placebo Non-Responder at Week 12	85	0	0	0
Overall Study COMPLETED	159	561	271	4
Overall Study NOT COMPLETED	53	70	38	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received Placebo intravenously (IV) or subcutaneously (SC) every 4 weeks (Q4W). Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 milligrams (mg) Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. Nonresponse is defined as failing to achieve at least a 30% decrease in stool frequency (SF) and/or abdominal pain (AP) and be no worse than baseline.	Mirikizumab Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 milligrams per kilogram (mg/kg) Ustekinumab IV for one dose, then 90 mg SC every 8 weeks (Q8W)	Mirikizumab (Adolescents) Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W
Overall Study Adverse Event	9	11	2	0
Overall Study Death	2	0	1	0
Overall Study Lack of Efficacy	14	11	7	1
Overall Study Lost to Follow-up	0	7	1	0
Overall Study As Reported by Investigator	2	6	6	0
Overall Study Physician Decision	3	2	1	0
Overall Study Pregnancy	2	2	1	0
Overall Study Withdrawal by Subject	20	28	18	1
Overall Study Non-Compliance	1	1	0	0
Overall Study Disposition Not Captured	0	2	1	0

Baseline Characteristics

A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=212 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=631 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab n=309 Participants Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W	Mirikizumab (Adolescent) n=6 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Total n=1158 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	27 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	205 Participants n=5 Participants	598 Participants n=7 Participants	295 Participants n=5 Participants	0 Participants n=4 Participants	1098 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	22 Participants n=7 Participants	8 Participants n=5 Participants	0 Participants n=4 Participants	33 Participants n=21 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	274 Participants n=7 Participants	161 Participants n=5 Participants	3 Participants n=4 Participants	525 Participants n=21 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	357 Participants n=7 Participants	148 Participants n=5 Participants	3 Participants n=4 Participants	633 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	0 Participants n=4 Participants	18 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	58 Participants n=7 Participants	25 Participants n=5 Participants	0 Participants n=4 Participants	99 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	192 Participants n=5 Participants	565 Participants n=7 Participants	278 Participants n=5 Participants	6 Participants n=4 Participants	1041 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Asian	44 Participants n=5 Participants	158 Participants n=7 Participants	78 Participants n=5 Participants	2 Participants n=4 Participants	282 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	5 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	0 Participants n=4 Participants	25 Participants n=21 Participants
Race (NIH/OMB) White	155 Participants n=5 Participants	448 Participants n=7 Participants	219 Participants n=5 Participants	4 Participants n=4 Participants	826 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	15 Participants n=21 Participants
Region of Enrollment United States	20 Participants n=5 Participants	66 Participants n=7 Participants	31 Participants n=5 Participants	0 Participants n=4 Participants	117 Participants n=21 Participants
Region of Enrollment Czechia	11 Participants n=5 Participants	29 Participants n=7 Participants	17 Participants n=5 Participants	0 Participants n=4 Participants	57 Participants n=21 Participants
Region of Enrollment Russia	22 Participants n=5 Participants	44 Participants n=7 Participants	20 Participants n=5 Participants	0 Participants n=4 Participants	86 Participants n=21 Participants
Region of Enrollment Austria	0 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment Latvia	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment Netherlands	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment South Korea	7 Participants n=5 Participants	40 Participants n=7 Participants	11 Participants n=5 Participants	2 Participants n=4 Participants	60 Participants n=21 Participants
Region of Enrollment China	31 Participants n=5 Participants	90 Participants n=7 Participants	43 Participants n=5 Participants	0 Participants n=4 Participants	164 Participants n=21 Participants
Region of Enrollment Brazil	11 Participants n=5 Participants	29 Participants n=7 Participants	18 Participants n=5 Participants	0 Participants n=4 Participants	58 Participants n=21 Participants
Region of Enrollment Poland	28 Participants n=5 Participants	83 Participants n=7 Participants	47 Participants n=5 Participants	3 Participants n=4 Participants	161 Participants n=21 Participants
Region of Enrollment Slovakia	2 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	0 Participants n=4 Participants	19 Participants n=21 Participants
Region of Enrollment France	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment Lithuania	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment Serbia	8 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	0 Participants n=4 Participants	21 Participants n=21 Participants
Region of Enrollment Croatia	1 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment Argentina	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Romania	1 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants
Region of Enrollment Hungary	5 Participants n=5 Participants	19 Participants n=7 Participants	10 Participants n=5 Participants	0 Participants n=4 Participants	34 Participants n=21 Participants
Region of Enrollment Japan	4 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	0 Participants n=4 Participants	28 Participants n=21 Participants
Region of Enrollment Ukraine	12 Participants n=5 Participants	43 Participants n=7 Participants	33 Participants n=5 Participants	0 Participants n=4 Participants	88 Participants n=21 Participants
Region of Enrollment United Kingdom	0 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment Switzerland	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment India	2 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	0 Participants n=4 Participants	25 Participants n=21 Participants
Region of Enrollment Spain	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment Canada	8 Participants n=5 Participants	19 Participants n=7 Participants	8 Participants n=5 Participants	0 Participants n=4 Participants	35 Participants n=21 Participants
Region of Enrollment Turkey	6 Participants n=5 Participants	28 Participants n=7 Participants	7 Participants n=5 Participants	0 Participants n=4 Participants	41 Participants n=21 Participants
Region of Enrollment Belgium	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
Region of Enrollment Denmark	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Italy	3 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment Mexico	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment Israel	4 Participants n=5 Participants	9 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	15 Participants n=21 Participants
Region of Enrollment Australia	8 Participants n=5 Participants	10 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	18 Participants n=21 Participants
Region of Enrollment Germany	8 Participants n=5 Participants	22 Participants n=7 Participants	8 Participants n=5 Participants	0 Participants n=4 Participants	38 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 12 to Week 52

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab)	9.0 percentage of participants Interval 5.1 to 13.0	38.0 percentage of participants Interval 34.0 to 42.0	—

PRIMARY outcome

Timeframe: Week 12 to Week 52

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Clinical response by PRO defined as ≥ 30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical remission defined as Crohn's Disease Activity Index (CDAI) total score \<150. The CDAI is an 8-item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter \[hematocrit\]).. Total score range of 0 to 600 points.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab)	19.6 percentage of participants Interval 14.1 to 25.1	45.4 percentage of participants Interval 41.4 to 49.5	—

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence \& size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; \>2 cm = 3); extent of ulcerated surface (none = 0; \<10% = 1; 10% to 30% = 2; \>30% = 3); extent of affected surface (none = 0; \<50% = 1; 50% to 75% = 2; \>75% = 3); presence \& type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed = 3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab)	12.6 percentage of participants Interval 8.0 to 17.2	32.5 percentage of participants Interval 28.7 to 36.3	—

SECONDARY outcome

Timeframe: Week 52

Population: All randomized participants who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug per protocol.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab n=287 Participants Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Endoscopic Response at Week 52	9 percentage of participants Interval 5.1 to 13.0	48.4 percentage of participants Interval 44.3 to 52.4	46.3 percentage of participants Interval 40.6 to 52.1

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Clinical remission defined as CDAI total score \<150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter \[hematocrit\]). Total score range of 0 to 600 points.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Clinical Remission at Week 12 (Placebo and Mirikizumab)	25.1 percentage of participants Interval 19.1 to 31.2	37.7 percentage of participants Interval 33.7 to 41.6	—

SECONDARY outcome

Timeframe: Week 52

Population: All randomized participants who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug per protocol.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab n=287 Participants Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Clinical Remission at Week 52	19.6 percentage of participants Interval 14.1 to 25.1	54.1 percentage of participants Interval 50.0 to 58.1	48.4 percentage of participants Interval 42.7 to 54.2

SECONDARY outcome

Timeframe: Week 12

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Endoscopic remission is defined as SES-CD Total Score ≤4 and at least a 2-point reduction from baseline and no subscore \>1. SES-CD evaluates 4 endoscopic variables in 5 bowel segments and each of the 20 individual variables is scored from 0-3: presence \& size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; \>2 cm = 3); extent of ulcerated surface (none = 0; \<10% = 1; 10% to 30% = 2; \>30% = 3); extent of affected surface (none = 0; \<50% = 1; 50% to 75% = 2; \>75% = 3); presence \& type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed =3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore \>1 is defined as no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) \>1.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Endoscopic Remission at Week 12 (Placebo and Mirikizumab)	4.0 percentage of participants Interval 1.3 to 6.7	10.9 percentage of participants Interval 8.3 to 13.4	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

The Urgency NRS is a single patient-reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency).

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Change From Baseline in Urgency Numeric Rating Scale (NRS) at Week 12 in Adult Participants (Placebo and Mirikizumab)	-1.58 score on a scale Standard Error 0.168	-2.44 score on a scale Standard Error 0.099	—

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Change From Baseline in Urgency NRS at Week 52 in Adult Participants (Placebo and Mirikizumab)	-1.23 score on a scale Standard Error 0.180	-3.24 score on a scale Standard Error 0.106	—

SECONDARY outcome

Timeframe: Week 12 to Week 52

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Clinical Response by PRO defined as ≥30% decrease in SF and/or AP \& neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical Remission by PRO defined as SF≤3 and not worse than baseline (as per Bristol Stool Scale Category 6 or 7) and AP ≤1 and no worse than baseline.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52 (Placebo and Mirikizumab)	19.6 percentage of participants Interval 14.1 to 25.1	45.4 percentage of participants Interval 41.4 to 49.5	—

SECONDARY outcome

Timeframe: Week 12 to Week 52

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Clinical Response by PRO defined as ≥30% decrease in SF and/or AP \& neither score worse than baseline. SF (number of liquid or very soft stools) per Bristol Stool Scale Category 6 or 7 \& AP (4-point scale:0=none,1=mild,2=moderate,3=severe). Endoscopic remission=SES-CD Total Score ≤4 \& at least 2-point reduction from baseline \& no subscore \>1.SES-CD evaluates 4 endoscopic variables in 5 bowel segments \& each of 20 individual variables scored 0-3: presence \& size of ulcers (none=0;diameter 0.1-0.5 cm=1;0.5-2 cm=2;\>2 cm=3);extent of ulcerated surface (none=0;\<10%=1;10% to 30%=2;\>30%=3);extent of affected surface (none=0;\<50%=1;50% to 75%=2;\>75%=3);presence \& type of narrowing (none=0;single,can be passed=1;multiple,can be passed=2;cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56;higher scores indicating more severe disease. No subscore \>1=no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) \>1

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52 (Placebo and Mirikizumab)	2.0 percentage of participants Interval 0.1 to 4.0	15.9 percentage of participants Interval 12.9 to 18.9	—

SECONDARY outcome

Timeframe: Week 12 to Week 52

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Clinical response by PRO defined as ≥30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical remission defined as CDAI total score \<150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter \[hematocrit\]). Total score range of 0 to 600 points. Corticosteroid-free clinical remission by CDAI is defined as achieving clinical remission by CDAI at Week 52 and being corticosteroid free from Week 40 to Week 52.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Corticosteroid-free Clinical Remission at Week 52 (Placebo and Mirikizumab)	18.6 percentage of participants Interval 13.2 to 24.0	43.7 percentage of participants Interval 39.7 to 47.7	—

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Change from baseline in CRP

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Change From Baseline in C-Reactive Protein (CRP) at Week 52 in Adult Participants (Placebo and Mirikizumab)	-0.08 milligram per liter (mg/L) Standard Error 0.087	-0.93 milligram per liter (mg/L) Standard Error 0.051	—

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug and had baseline fecal calprotectin.

Change from baseline in Fecal Calprotectin

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Change From Baseline in Fecal Calprotectin at Week 52 in Adult Participants (Placebo and Mirikizumab)	-0.19 micrograms per gram (μg/g) Standard Error 0.117	-1.41 micrograms per gram (μg/g) Standard Error 0.067	—

SECONDARY outcome

Timeframe: Week 12 to Week 52

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=132 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Resolution of Baseline Extraintestinal Manifestations (EIMs) at Week 52 (Placebo and Mirikizumab)	14.6 percentage of participants	43.2 percentage of participants	—

SECONDARY outcome

Timeframe: Week 12 to Week 52

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=38 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Clinical Response at Week 12 and ≥50% Reduction in Number of Draining Cutaneous Fistulae at Week 52 in Participants With Draining Cutaneous Fistulae at Baseline (Placebo and Mirikizumab)	16.7 percentage of participants Interval 0.0 to 33.9	21.1 percentage of participants Interval 8.1 to 34.0	—

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

The IBDQ is a 32-item patient completed questionnaire that measures 4 aspects of patients' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function. Responses are graded on a 7-point Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." IBDQ total score is calculated as the sum of all questions. Scores range from 32 to 224; a higher score indicates a better quality of life.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Change From Baseline in Health Related Quality of Life at Week 52 in Adult Participants: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Placebo and Mirikizumab)	15.9 score on a scale Standard Error 2.316	43.82 score on a scale Standard Error 1.365	—

SECONDARY outcome

Timeframe: 900 mg Mirikizumab: Week 4: Predose; Week 4, Day 1: Postdose; Week 8, 12: Predose 300 mg Mirikizumab: Week 16, 24, 36: Predose; Week 52

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.

PopPK: AUC of Mirikizumab

Outcome measures

Outcome measures
Measure	Placebo n=711 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=711 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Adult Population Pharmacokinetics (PopPK): Area Under the Concentration Time Curve (AUC) of Mirikizumab	1820 microgramsday per milliliter(ugday/mL) Geometric Coefficient of Variation 38.1	220 microgramsday per milliliter(ugday/mL) Geometric Coefficient of Variation 55.9	—

POST_HOC outcome

Timeframe: Week 12

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Alternate endoscopic remission is defined as SES-CD Total Score ≤4 and at least a 2-point reduction from baseline and no subscore \>1. SES-CD evaluates 4 endoscopic variables in 5 bowel segments and each of the 20 individual variables is scored from 0-3: presence \& size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; \>2 cm = 3); extent of ulcerated surface (none = 0; \<10% = 1; 10% to 30% = 2; \>30% = 3); extent of affected surface (none = 0; \<50% = 1; 50% to 75% = 2; \>75% = 3); presence \& type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed =3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore \>1 is defined as no subscore \>1 in any of the 20 individual variables.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Alternate Endoscopic Remission at Week 12 (Placebo and Mirikizumab)	7.0 percentage of participants Interval 1.9 to 12.1	17.6 percentage of participants Interval 13.2 to 22.1	—

POST_HOC outcome

Timeframe: Week 12 to Week 52

Population: All randomized participants in Placebo and Mirikizumab arms who have baseline SES-CD ≥7 (or ≥4 for isolated ileal disease) and received at least one dose of study drug.

Clinical Response by PRO defined as ≥30% decrease in SF and/or AP \& neither score worse than baseline. SF (number of liquid or very soft stools) per Bristol Stool Scale Category 6 or 7 \& AP (4-point scale:0=none,1=mild,2=moderate,3=severe). Alternate endoscopic remission defined as SES-CD Total Score ≤4 \& at least 2-point reduction from baseline \& no subscore \>1.SES-CD evaluates 4 endoscopic variables in 5 bowel segments \& each of 20 individual variables scored 0-3: presence \& size of ulcers (none=0;diameter 0.1-0.5 cm=1;0.5-2 cm=2;\>2 cm=3); extent of ulcerated surface (none=0;\<10%=1;10% to 30%=2;\>30%=3);extent of affected surface (none=0;\<50%=1;50% to 75%=2;\>75%=3); presence \& type of narrowing (none=0;single,can be passed=1;multiple,can be passed=2;cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore \>1 is defined as no subscore \>1 in any of the 20 individual variables.

Outcome measures

Outcome measures
Measure	Placebo n=199 Participants Participants received Placebo IV or SC Q4W. Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=579 Participants Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Alternate Endoscopic Remission at Week 52 (Placebo and Mirikizumab)	4.0 percentage of participants Interval 0.1 to 7.9	23.5 percentage of participants Interval 18.5 to 28.4	—

Adverse Events

Placebo

Serious events: 37 serious events

Other events: 66 other events

Deaths: 1 deaths

Placebo Non-Responders

Serious events: 7 serious events

Other events: 27 other events

Deaths: 1 deaths

Mirikizumab

Serious events: 65 serious events

Other events: 300 other events

Deaths: 0 deaths

Ustekinumab

Serious events: 35 serious events

Other events: 131 other events

Deaths: 1 deaths

Mirikizumab (Adolescents)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=211 participants at risk Participants received Placebo IV or SC Q4W	Placebo Non-Responders n=85 participants at risk Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=630 participants at risk Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab n=309 participants at risk Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W	Mirikizumab (Adolescents) n=6 participants at risk Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W
Gastrointestinal disorders Inguinal hernia	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Blood and lymphatic system disorders Anaemia	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 2/630 • Number of events 3 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Cardiac disorders Angina pectoris	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Cardiac disorders Atrial fibrillation	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Cardiac disorders Cardiac arrest	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Cardiac disorders Cardiac failure acute	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Cardiac disorders Cardio-respiratory arrest	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/125 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/48 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/356 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.68% 1/148 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/3 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Abdominal pain	0.95% 2/211 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 2/630 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Abdominal pain lower	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Anal fistula	1.9% 4/211 • Number of events 4 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Anorectal disorder	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Colitis	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Crohn's disease	6.6% 14/211 • Number of events 14 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	2.4% 2/85 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	1.9% 12/630 • Number of events 12 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	3.6% 11/309 • Number of events 16 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Diarrhoea	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 2/630 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Enteritis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Enterocolonic fistula	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Gastrointestinal disorder	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Ileal stenosis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Ileus	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	1.2% 1/85 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 2/630 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Intestinal obstruction	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	1.2% 1/85 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.48% 3/630 • Number of events 4 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Intestinal perforation	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	1.2% 1/85 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Large intestine perforation	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 2/630 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Nausea	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Obstruction gastric	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Rectal stenosis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Small intestinal obstruction	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.63% 4/630 • Number of events 5 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Subileus	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.65% 2/309 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
General disorders Oedema	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
General disorders Pyrexia	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
General disorders Swelling	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Hepatobiliary disorders Bile duct stone	0.95% 2/211 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Hepatobiliary disorders Cholangitis	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Hepatobiliary disorders Cholecystitis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Hepatobiliary disorders Cholelithiasis	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Immune system disorders Anaphylactic reaction	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Immune system disorders Infusion related hypersensitivity reaction	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Abdominal abscess	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 2/630 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Abscess intestinal	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Abscess limb	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Anal abscess	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 2/630 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.65% 2/309 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Appendicitis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Cellulitis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Clostridium difficile colitis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Clostridium difficile infection	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Covid-19	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 2/630 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.65% 2/309 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Covid-19 pneumonia	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Fournier's gangrene	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Gastroenteritis	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Liver abscess	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Pelvic abscess	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Peritonitis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Pneumonia	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Pneumonia aspiration	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Salpingitis	1.2% 1/86 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/37 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/274 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/161 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/3 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Sepsis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Septic shock	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Urinary tract infection	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Urosepsis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Injury, poisoning and procedural complications Anastomotic stenosis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Injury, poisoning and procedural complications Procedural intestinal perforation	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	1.2% 1/85 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Metabolism and nutrition disorders Dehydration	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Metabolism and nutrition disorders Malnutrition	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 3 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Nervous system disorders Cerebrovascular accident	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Nervous system disorders Headache	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Nervous system disorders Loss of consciousness	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Nervous system disorders Myoclonic epilepsy	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Nervous system disorders Syncope	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Psychiatric disorders Panic disorder	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Renal and urinary disorders Hydronephrosis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	1.2% 1/85 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Surgical and medical procedures Anal fistula repair	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Surgical and medical procedures Ileectomy	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Vascular disorders Haemorrhage	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Vascular disorders Hypotension	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.

Other adverse events

Other adverse events
Measure	Placebo n=211 participants at risk Participants received Placebo IV or SC Q4W	Placebo Non-Responders n=85 participants at risk Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study.	Mirikizumab n=630 participants at risk Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Ustekinumab n=309 participants at risk Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC Q8W	Mirikizumab (Adolescents) n=6 participants at risk Participants received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W
Blood and lymphatic system disorders Anaemia	4.7% 10/211 • Number of events 11 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	10.6% 9/85 • Number of events 10 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	6.8% 43/630 • Number of events 49 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	4.9% 15/309 • Number of events 20 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Crohn's disease	10.0% 21/211 • Number of events 22 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	4.7% 4/85 • Number of events 4 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	2.7% 17/630 • Number of events 19 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	4.5% 14/309 • Number of events 16 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Diarrhoea	3.8% 8/211 • Number of events 8 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	1.2% 1/85 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	5.2% 33/630 • Number of events 35 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	3.9% 12/309 • Number of events 16 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	1.7% 11/630 • Number of events 11 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.65% 2/309 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Gastrointestinal disorders Vomiting	0.95% 2/211 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	2.4% 2/85 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	3.8% 24/630 • Number of events 25 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	1.9% 6/309 • Number of events 6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
General disorders Pyrexia	2.4% 5/211 • Number of events 5 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	2.4% 2/85 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	4.3% 27/630 • Number of events 35 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	2.9% 9/309 • Number of events 13 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Immune system disorders Hypersensitivity	0.47% 1/211 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.48% 3/630 • Number of events 5 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.65% 2/309 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Covid-19	10.0% 21/211 • Number of events 22 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	7.1% 6/85 • Number of events 7 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.3% 103/630 • Number of events 106 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	14.9% 46/309 • Number of events 48 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Epstein-barr virus infection	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Gastroenteritis	2.4% 5/211 • Number of events 5 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	2.4% 15/630 • Number of events 18 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	2.6% 8/309 • Number of events 9 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Nasopharyngitis	3.8% 8/211 • Number of events 10 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	1.2% 1/85 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	5.7% 36/630 • Number of events 52 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	6.1% 19/309 • Number of events 20 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Pharyngotonsillitis	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Pustule	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Infections and infestations Upper respiratory tract infection	3.3% 7/211 • Number of events 10 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	8.2% 7/85 • Number of events 8 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	6.0% 38/630 • Number of events 43 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	7.1% 22/309 • Number of events 24 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/6 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/630 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/309 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Investigations Sars-cov-2 test positive	0.00% 0/211 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.00% 0/85 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.16% 1/630 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	0.32% 1/309 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Musculoskeletal and connective tissue disorders Arthralgia	4.7% 10/211 • Number of events 11 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	3.5% 3/85 • Number of events 3 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	6.5% 41/630 • Number of events 48 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	2.6% 8/309 • Number of events 9 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.
Nervous system disorders Headache	2.8% 6/211 • Number of events 10 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	1.2% 1/85 • Number of events 1 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	6.5% 41/630 • Number of events 58 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	4.9% 15/309 • Number of events 15 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.	16.7% 1/6 • Number of events 2 • Baseline up to follow up (up to 68 weeks) All randomized participants who received one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. As per the pre-specified safety analysis, adverse events were reported by treatment regimen, and the placebo participants who did not meet response criteria at the 12-week assessment and initiated mirikizumab were censored from the Placebo arm at Week 12 and reported under Placebo Non-Responders.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60