A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02899988
• Collaborator: (none)
• Enrollment: 205
• Locations: 40
• Arms: 4
• Actual Duration (Months): 31.7
• Patients Per Site: 5.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Plaque Psoriasis	Drug: Mirikizumab; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects With Moderate-to- Severe Plaque Psoriasis
• Actual Study Start Date: Sep 14, 2016
• Actual Primary Completion Date: Jun 19, 2017
• Actual Study Completion Date: May 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 30 mg Mirikizumab 30 mg Mirikizumab administered subcutaneously (SC) every 8 weeks (Q8W).	Drug: Mirikizumab; Administered SC; Other Names: LY3074828
Experimental: 100 mg Mirikizumab 100 mg Mirikizumab administered SC Q8W.	Drug: Mirikizumab; Administered SC; Other Names: LY3074828
Experimental: 300 mg Mirikizumab 300 mg Mirikizumab administered SC Q8W.	Drug: Mirikizumab; Administered SC; Other Names: LY3074828
Placebo Comparator: Placebo Placebo administered SC Q8W.	Drug: Placebo; Administered SC

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) [Week 16]

   PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).

Secondary Outcome Measures

1. Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) [Week 16]

   The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no PsO to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).

2. Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) [Week 16]

   The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no PsO to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).

3. Percentage of Participants With a Static Physician Global Assessment (sPGA) 0 and 0/1 [Week 16]

   The sPGA is the physician's determination of the participant's PsO lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 16 were considered non-responders for non-responder Imputation (NRI) analysis.

4. Mean Change From Baseline on the Psoriasis Symptom Scale (PSS) Total Score [Baseline, Week 16]

   PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. The total score was calculated by summing the 8 individual items and ranged from 0 to 80, higher scores indicated greater symptom/sign severity. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region [United States/Outside United States (US/OUS)], previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = heterogeneous autoregressive.

5. Mean Change (Improvement) From Baseline on the Patient Global Assessment [Baseline, Week 16]

   The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.

6. Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) Total Score [Baseline, Week 16]

   The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.

7. Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores [Baseline, Week 16]

   The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, geographic region (US/OUS), and previous therapy (yes/no) as fixed factors and baseline value as covariate.

8. Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline Through Week 104 [Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 52, Week 56, Week 64, Week 72, Week 80, Week 88, Week 96, Week 100, Week 104]

   Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline through Week 104

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following criteria:

• plaque psoriasis involving ≥10% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening and baseline

• sPGA score of ≥3 at screening and baseline

• Candidate for biologic treatment for psoriasis.

Exclusion Criteria:

• Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data.

• Breastfeeding or nursing (lactating) women.

• Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening.

• Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study.

• Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results.

• Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline.

• Have received topical psoriasis treatment within 14 days prior to baseline.

• Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 8 weeks prior to baseline.

• Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renstar Medical Research	Ocala	Florida	United States	34471
2	Forward Clinical Trials, Inc	Tampa	Florida	United States	33624
3	The Indiana Clinical Trials Center, PC	Plainfield	Indiana	United States	46168
4	The South Bend Clinic	South Bend	Indiana	United States	46617
5	DS Research	Louisville	Kentucky	United States	40241
6	Dr. Shondra Smith MD	Lake Charles	Louisiana	United States	70605
7	Central Dermatology PC	Saint Louis	Missouri	United States	63117
8	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey	United States	08520
9	Oregon Dermatology and Research Center	Portland	Oregon	United States	97210
10	Clinical Partners LLC	Johnston	Rhode Island	United States	02919
11	Menter Dermatology Research Institute	Dallas	Texas	United States	75246
12	Dermatology Associates	Seattle	Washington	United States	98101
13	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Calgary		Canada	T2G 1B1
14	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Halifax		Canada	B3H1Z2
15	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Montreal		Canada	H2K4L5
16	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Peterborough		Canada	K9J 5K2
17	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Richmond Hill		Canada	L4B 1A5
18	For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.	Waterloo		Canada	N2J 1C4
19	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Frankfurt am Main		Germany	60590
20	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hamburg		Germany	20354
21	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mahlow		Germany	15831
22	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gifu		Japan	501-1194
23	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kurume		Japan	830-0011
24	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Morioka		Japan	020-8505
25	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nagoya		Japan	467-8602
26	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Osaka		Japan	545-8586
27	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Shinagawa-KU		Japan	141-8625
28	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Shinjuku-ku		Japan	169-0073
29	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Takaoka-shi		Japan	9330871
30	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tsu-shi		Japan	514-8507
31	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bialystok		Poland	15-017
32	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bialystok		Poland	15-351
33	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lodz		Poland	90-242
34	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lodz		Poland	90-265
35	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Swidnik		Poland	21-040
36	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Warsaw		Poland	01-518
37	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Warszawa		Poland	02-507
38	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Wroclaw		Poland	51-318
39	Grupo Dermatologico de Carolina	Carolina		Puerto Rico	00985
40	Ponce School of Medicine CAIMED Center	Ponce		Puerto Rico	00716

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

• Study Protocol - Aug 21, 2018
• Statistical Analysis Plan - Jun 28, 2017

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02899988
• Other Study ID Numbers: 16481; I6T-MC-AMAF; 2016-001098-34
• First Posted: Sep 14, 2016
• Last Update Posted: Jun 18, 2020
• Last Verified: Aug 15, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Eli Lilly and Company: IL-23; dermatology
• Additional relevant MeSH terms: Psoriasis; Mirikizumab

Study Results

Participant Flow

Arm/Group Title	Induction: Placebo	Induction: 30 mg Mirikizumab Q8W	Induction:100 mg Mirikizumab Q8W	Induction: 300 mg Mirikizumab Q8W	Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN	Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN	Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN	Maintenance: Placebo to 300 mg Mirikizumab Q8W	Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W	Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W	Maintenance: 300 mg Mirikizumab Q8W
Arm/Group Description	Induction: Participants received placebo subcutaneously (SC) every 8 weeks (Q8W) during Induction period.	Induction: Participants received 30 milligram (mg) mirikizumab SC Q8W during Induction period.	Induction: Participants received 100 mg mirikizumab SC Q8W during Induction period.	Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.	Maintenance: Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period. Participants who had greater than or equal to (≥) Psoriasis Area and Severity Index (PASI) 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.	Maintenance: Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.	Maintenance: Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.	Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period. Follow-up: Participants did not receive drug during the follow-up period.	Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had less than (<) PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period. Follow-up: Participants did not receive drug during the follow-up period.	Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.	Maintenance: Participants who had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
Period Title: Induction Period (16 Weeks)
STARTED	52	51	51	51	0	0	0	0	0	0	0
Received at Least One Dose of Study Drug	52	51	51	51	0	0	0	0	0	0	0
COMPLETED	50	49	51	49	0	0	0	0	0	0	0
NOT COMPLETED	2	2	0	2	0	0	0	0	0	0	0
Period Title: Induction Period (16 Weeks)
STARTED	0	0	0	0	15	30	34	50	34	21	15
Rescue Participants	0	0	0	10	0	0	0	0	0	0	0
Roll Over to AMAH (NCT03556202)	0	0	0	13	9	18	26	42	24	17	0
COMPLETED	0	0	0	0	13	27	30	45	30	19	13
NOT COMPLETED	0	0	0	0	2	3	4	5	4	2	2
Period Title: Induction Period (16 Weeks)
STARTED	0	0	0	0	2	4	3	3	6	2	0
COMPLETED	0	0	0	0	2	4	3	3	6	2	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Induction: Placebo	Induction: 30 mg Mirikizumab	Induction: 100 mg Mirikizumab	Induction: 300 mg Mirikizumab	Total
Arm/Group Description	Induction: Placebo administered SC Q8W during Induction period.	Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.	Total of all reporting groups
Overall Participants	52	51	51	51	205
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.0 (12.39)	49.2 (13.28)	46.0 (13.18)	47.5 (13.23)	47.2 (12.99)
Sex: Female, Male (Count of Participants)
Female	10 19.2%	12 23.5%	16 31.4%	15 29.4%	53 25.9%
Male	42 80.8%	39 76.5%	35 68.6%	36 70.6%	152 74.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 15.4%	7 13.7%	4 7.8%	5 9.8%	24 11.7%
Not Hispanic or Latino	39 75%	37 72.5%	42 82.4%	42 82.4%	160 78%
Unknown or Not Reported	5 9.6%	7 13.7%	5 9.8%	4 7.8%	21 10.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	6 11.5%	7 13.7%	7 13.7%	6 11.8%	26 12.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	1 1.9%	1 2%	3 5.9%	3 5.9%	8 3.9%
White	44 84.6%	43 84.3%	41 80.4%	42 82.4%	170 82.9%
More than one race	1 1.9%	0 0%	0 0%	0 0%	1 0.5%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Canada	4 7.7%	7 13.7%	7 13.7%	5 9.8%	23 11.2%
United States	21 40.4%	20 39.2%	18 35.3%	23 45.1%	82 40%
Japan	4 7.7%	7 13.7%	5 9.8%	4 7.8%	20 9.8%
Poland	19 36.5%	14 27.5%	18 35.3%	14 27.5%	65 31.7%
Germany	4 7.7%	3 5.9%	3 5.9%	5 9.8%	15 7.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
Description	PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Induction: Placebo	Induction: 30 mg Mirikizumab	Induction: 100 mg Mirikizumab	Induction: 300 mg Mirikizumab
Arm/Group Description	Induction: Placebo administered SC Q8W during Induction period.	Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
Measure Participants	52	51	51	51
Number (95% Confidence Interval) [percentage of participants]	0 0%	29.4 57.6%	58.8 115.3%	66.7 130.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 30 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	29.4
	Confidence Interval	(2-Sided) 95%; 16.9 to 41.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 100 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	58.8
	Confidence Interval	(2-Sided) 95%; 45.3 to 72.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 300 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	66.7
	Confidence Interval	(2-Sided) 95%; 53.7 to 79.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Description	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no PsO to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Induction: Placebo	Induction: 30 mg Mirikizumab	Induction: 100 mg Mirikizumab	Induction: 300 mg Mirikizumab
Arm/Group Description	Induction: Placebo administered SC Q8W during Induction period.	Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
Measure Participants	52	51	51	51
Number (95% Confidence Interval) [percentage of participants]	0 0%	15.7 30.8%	31.4 61.6%	31.4 61.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 30 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.039
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	15.7
	Confidence Interval	(2-Sided) 95%; 5.7 to 25.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 100 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	31.4
	Confidence Interval	(2-Sided) 95%; 18.6 to 44.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 300 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	31.4
	Confidence Interval	(2-Sided) 95%; 18.6 to 44.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Description	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no PsO to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease).
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug.

Arm/Group Title	Induction: Placebo	Induction: 30 mg Mirikizumab	Induction: 100 mg Mirikizumab	Induction: 300 mg Mirikizumab
Arm/Group Description	Induction: Placebo administered SC Q8W during Induction period.	Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
Measure Participants	52	51	51	51
Number (95% Confidence Interval) [percentage of participants]	3.8 7.3%	52.9 103.7%	78.4 153.7%	74.5 146.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 30 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	22.49
	Confidence Interval	(2-Sided) 95%; 5.62 to 89.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 100 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	74.6
	Confidence Interval	(2-Sided) 95%; 62.1 to 87.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 300 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	70.7
	Confidence Interval	(2-Sided) 95%; 57.6 to 83.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants With a Static Physician Global Assessment (sPGA) 0 and 0/1
Description	The sPGA is the physician's determination of the participant's PsO lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 16 were considered non-responders for non-responder Imputation (NRI) analysis.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of drug.

Arm/Group Title	Induction: Placebo	Induction: 30 mg Mirikizumab	Induction: 100 mg Mirikizumab	Induction: 300 mg Mirikizumab
Arm/Group Description	Induction: Placebo administered SC Q8W during Induction period.	Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
Measure Participants	52	51	51	51
sPGA (0)	0 0%	15.7 30.8%	31.4 61.6%	31.4 61.6%
sPGA (0/1)	1.9 3.7%	37.3 73.1%	70.6 138.4%	68.6 134.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 30 mg Mirikizumab
	Comments	sPGA (0)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.041
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	15.7
	Confidence Interval	(2-Sided) 95%; 5.7 to 25.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 100 mg Mirikizumab
	Comments	sPGA (0)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	31.4
	Confidence Interval	(2-Sided) 95%; 18.6 to 44.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 300 mg Mirikizumab
	Comments	sPGA (0)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	31.4
	Confidence Interval	(2-Sided) 95%; 18.6 to 44.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 30 mg Mirikizumab
	Comments	sPGA (0/1)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	35.3
	Confidence Interval	(2-Sided) 95%; 21.5 to 49.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 100 mg Mirikizumab
	Comments	sPGA (0/1)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	68.7
	Confidence Interval	(2-Sided) 95%; 55.6 to 81.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 300 mg Mirikizumab
	Comments	sPGA (0/1)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	66.7
	Confidence Interval	(2-Sided) 95%; 53.4 to 80.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Mean Change From Baseline on the Psoriasis Symptom Scale (PSS) Total Score
Description	PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. The total score was calculated by summing the 8 individual items and ranged from 0 to 80, higher scores indicated greater symptom/sign severity. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region [United States/Outside United States (US/OUS)], previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = heterogeneous autoregressive.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug who had baseline and at least one post-baseline PSS observation.

Arm/Group Title	Induction: Placebo	Induction: 30 mg Mirikizumab	Induction: 100 mg Mirikizumab	Induction: 300 mg Mirikizumab
Arm/Group Description	Induction: Placebo administered SC Q8W during Induction period.	Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
Measure Participants	43	43	44	44
Least Squares Mean (Standard Error) [units on a scale]	-4.35 (2.29)	-31.19 (2.34)	-42.33 (2.37)	-33.66 (2.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 30 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-26.84
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.26
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 100 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-37.99
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.29
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 300 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-29.32
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.22
	Estimation Comments

6. Secondary Outcome

Title	Mean Change (Improvement) From Baseline on the Patient Global Assessment
Description	The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug who had baseline and at least one post-baseline Patient Global Assessment observation.

Arm/Group Title	Induction: Placebo	Induction: 30 mg Mirikizumab	Induction: 100 mg Mirikizumab	Induction: 300 mg Mirikizumab
Arm/Group Description	Induction: Placebo administered SC Q8W during Induction period.	Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 100 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
Measure Participants	51	48	51	49
Least Squares Mean (Standard Error) [units on a scale]	0.35 (0.16)	2.24 (0.16)	2.91 (0.16)	2.82 (0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 30 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.90
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 100 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.56
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 300 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.47
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments

7. Secondary Outcome

Title	Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) Total Score
Description	The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug who had baseline and at least one post-baseline DLQI observation.

Arm/Group Title	Induction: Placebo	Induction: 30 mg Mirikizumab	Induction: 100 mg Mirikizumab	Induction: 300 mg Mirikizumab
Arm/Group Description	Induction: Placebo administered SC Q8W during Induction period.	Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 100 mg Mirikizumab administered SC Q8W during Induction period	Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
Measure Participants	51	48	51	49
Least Squares Mean (Standard Error) [score on a scale]	-1.07 (0.69)	-9.19 (0.71)	-10.18 (0.69)	-9.64 (0.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 30 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.12
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.98
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 100 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.11
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.97
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 300 mg Mirikizumab
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.57
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.98
	Estimation Comments

8. Secondary Outcome

Title	Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
Description	The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, geographic region (US/OUS), and previous therapy (yes/no) as fixed factors and baseline value as covariate.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

All participants who received at least one dose of study drug with a baseline value and at least 1 post-baseline value.

Arm/Group Title	Induction: Placebo	Induction: 30 mg Mirikizumab	Induction: 100 mg Mirikizumab	Induction: 300 mg Mirikizumab
Arm/Group Description	Induction: Placebo administered SC Q8W during Induction period.	Induction: 30 mg Mirikizumab administered SC Q8W during Induction period.	Induction: 100 mg Mirikizumab administered SC Q8W during Induction period	Induction: 300 mg Mirikizumab administered SC Q8W during Induction period.
Measure Participants	51	48	51	49
MCS	0.28 (0.87)	2.39 (0.90)	2.74 (0.88)	1.52 (0.88)
PCS	1.23 (0.84)	4.58 (0.88)	4.40 (0.85)	5.09 (0.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 30 mg Mirikizumab
	Comments	Mental Component Summary (MCS)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.11
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.24
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 100 mg Mirikizumab
	Comments	Mental Component Summary (MCS)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.74
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.22
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 300 mg Mirikizumab
	Comments	Mental Component Summary (MCS)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.087
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.52
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.24
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 30 mg Mirikizumab
	Comments	Physical Component Summary
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.35
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.20
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 100 mg Mirikizumab
	Comments	Physical Component Summary
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.16
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.18
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Induction: Placebo, Induction: 300 mg Mirikizumab
	Comments	Physical Component Summary
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.86
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.19
	Estimation Comments

9. Secondary Outcome

Title	Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline Through Week 104
Description	Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline through Week 104
Time Frame	Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 52, Week 56, Week 64, Week 72, Week 80, Week 88, Week 96, Week 100, Week 104

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN	100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN	300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN	Placebo to 300 mg Mirikizumab Q8W	30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W	100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W	300 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
Arm/Group Description	Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.	Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.	Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.	Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period.	Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.	Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.	Participants received 300 mg mirikizumab SC Q8W during Induction period. Participants had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
Measure Participants	13	23	33	50	34	21	15
Geometric Mean (Geometric Coefficient of Variation) [nanogram*hour per milliliter (ng*hr/mL)]	3.22 (46.33)	8.94 (79.19)	22.96 (55.80)	46.4 (62.8)	34.83 (92.13)	47.66 (70.08)	51.30 (43.54)

Adverse Events

Time Frame	Up To 120 Weeks
Adverse Event Reporting Description	All participants who received at least one dose of study drug.Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Arm/Group Title	Induction: Placebo		Induction: 30 mg Mirikizumab Q8W		Induction:100 mg Mirikizumab Q8W		Induction: 300 mg Mirikizumab Q8W		Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN		Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN		Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN		Maintenance: Placebo to 300 mg Mirikizumab Q8W		Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W		Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W		Maintenance: 300 mg Mirikizumab Q8W		300 mg Mirikizumab Q8W-Rescue		30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up		100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up		300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up		Placebo to 300 mg Mirikizumab Q8W-Follow-up		30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up		100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
Arm/Group Description	Induction: Participants received placebo SC Q8W during Induction period.		Induction: Participants received 30 mg mirikizumab Q8W during Induction period.		Induction: Participants received 100 mg mirikizumab SC Q8W during Induction period.		Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.		Maintenance: Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period. Participants who had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.		Maintenance: Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.		Maintenance: Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.		Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period.		Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.		Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.		Maintenance: Participants who had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.		Participants received 300 mg Q8W mirikizumab during rescue.		Follow-up: Participants did not receive drug during the follow-up period.		Follow-up: Participants did not receive drug during the follow-up period.		Follow-up: Participants did not receive drug during the follow-up period.		Follow-up: Participants did not receive drug during the follow-up period.		Follow-up: Participants did not receive drug during the follow-up period.		Follow-up: Participants did not receive drug during the follow-up period.
All Cause Mortality
	Induction: Placebo		Induction: 30 mg Mirikizumab Q8W		Induction:100 mg Mirikizumab Q8W		Induction: 300 mg Mirikizumab Q8W		Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN		Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN		Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN		Maintenance: Placebo to 300 mg Mirikizumab Q8W		Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W		Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W		Maintenance: 300 mg Mirikizumab Q8W		300 mg Mirikizumab Q8W-Rescue		30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up		100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up		300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up		Placebo to 300 mg Mirikizumab Q8W-Follow-up		30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up		100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/51 (0%)		0/51 (0%)		0/51 (0%)		0/15 (0%)		0/30 (0%)		0/34 (0%)		0/50 (0%)		0/34 (0%)		0/21 (0%)		0/15 (0%)		0/10 (0%)		0/2 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)
Serious Adverse Events
	Induction: Placebo		Induction: 30 mg Mirikizumab Q8W		Induction:100 mg Mirikizumab Q8W		Induction: 300 mg Mirikizumab Q8W		Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN		Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN		Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN		Maintenance: Placebo to 300 mg Mirikizumab Q8W		Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W		Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W		Maintenance: 300 mg Mirikizumab Q8W		300 mg Mirikizumab Q8W-Rescue		30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up		100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up		300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up		Placebo to 300 mg Mirikizumab Q8W-Follow-up		30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up		100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/52 (1.9%)		1/51 (2%)		0/51 (0%)		1/51 (2%)		1/15 (6.7%)		2/30 (6.7%)		1/34 (2.9%)		2/50 (4%)		2/34 (5.9%)		2/21 (9.5%)		3/15 (20%)		1/10 (10%)		0/2 (0%)		0/4 (0%)		0/3 (0%)		0/3 (0%)		0/6 (0%)		0/2 (0%)
Cardiac disorders
Atrial fibrillation	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Gastrointestinal disorders
Enlarged uvula	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	1/34 (2.9%)	1	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
General disorders
Non-cardiac chest pain	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	1	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Infections and infestations
Endocarditis bacterial	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	1/30 (3.3%)	1	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Erysipelas	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Pneumonia	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Pyelonephritis acute	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	1/34 (2.9%)	1	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Injury, poisoning and procedural complications
Femur fracture	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	1/21 (4.8%)	1	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Investigations
Alanine aminotransferase increased	0/52 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Aspartate aminotransferase increased	0/52 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	1/21 (4.8%)	1	0/15 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Intraocular melanoma	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	1/30 (3.3%)	1	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Lung neoplasm malignant	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	1	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Nervous system disorders
Cerebral haemorrhage	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Psychiatric disorders
Suicidal ideation	1/52 (1.9%)	1	0/51 (0%)	0	0/51 (0%)	0	1/51 (2%)	1	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Renal and urinary disorders
Nephrolithiasis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	1/34 (2.9%)	1	0/50 (0%)	0	1/34 (2.9%)	1	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Surgical and medical procedures
Nasal septal operation	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	1/34 (2.9%)	1	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Other (Not Including Serious) Adverse Events
	Induction: Placebo		Induction: 30 mg Mirikizumab Q8W		Induction:100 mg Mirikizumab Q8W		Induction: 300 mg Mirikizumab Q8W		Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN		Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN		Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN		Maintenance: Placebo to 300 mg Mirikizumab Q8W		Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W		Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W		Maintenance: 300 mg Mirikizumab Q8W		300 mg Mirikizumab Q8W-Rescue		30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up		100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up		300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up		Placebo to 300 mg Mirikizumab Q8W-Follow-up		30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up		100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/52 (36.5%)		24/51 (47.1%)		19/51 (37.3%)		19/51 (37.3%)		13/15 (86.7%)		20/30 (66.7%)		23/34 (67.6%)		38/50 (76%)		28/34 (82.4%)		18/21 (85.7%)		13/15 (86.7%)		9/10 (90%)		0/2 (0%)		1/4 (25%)		0/3 (0%)		0/3 (0%)		2/6 (33.3%)		1/2 (50%)
Blood and lymphatic system disorders
Anaemia	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Cardiac disorders
Atrial fibrillation	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	2	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Myocardial infarction	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Ear and labyrinth disorders
Vertigo	1/52 (1.9%)	1	1/51 (2%)	1	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	1/34 (2.9%)	1	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	2/15 (13.3%)	2	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Eye disorders
Cataract	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	1/30 (3.3%)	2	0/34 (0%)	0	1/50 (2%)	1	1/34 (2.9%)	2	0/21 (0%)	0	1/15 (6.7%)	2	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/52 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	2	0/34 (0%)	0	1/21 (4.8%)	1	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Abdominal tenderness	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Diarrhoea	1/52 (1.9%)	1	0/51 (0%)	0	1/51 (2%)	1	3/51 (5.9%)	3	2/15 (13.3%)	2	0/30 (0%)	0	1/34 (2.9%)	1	2/50 (4%)	2	1/34 (2.9%)	1	0/21 (0%)	0	2/15 (13.3%)	3	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Duodenal ulcer	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Gastritis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	2/50 (4%)	3	1/34 (2.9%)	1	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Gastrooesophageal reflux disease	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	1	1/34 (2.9%)	1	1/21 (4.8%)	1	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Irritable bowel syndrome	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Large intestine polyp	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	1/34 (2.9%)	1	0/21 (0%)	0	0/15 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Nausea	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/51 (2%)	1	0/15 (0%)	0	1/30 (3.3%)	1	2/34 (5.9%)	2	0/50 (0%)	0	1/34 (2.9%)	1	1/21 (4.8%)	1	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Periodontal disease	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	1/34 (2.9%)	1	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Toothache	0/52 (0%)	0	1/51 (2%)	1	1/51 (2%)	1	1/51 (2%)	1	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	2/34 (5.9%)	3	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Vomiting	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	1	1/34 (2.9%)	1	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
General disorders
Fatigue	0/52 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	1	1/34 (2.9%)	1	1/21 (4.8%)	1	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Injection site pain	1/52 (1.9%)	2	3/51 (5.9%)	15	3/51 (5.9%)	14	2/51 (3.9%)	9	1/15 (6.7%)	9	1/30 (3.3%)	6	1/34 (2.9%)	3	4/50 (8%)	92	3/34 (8.8%)	67	2/21 (9.5%)	31	0/15 (0%)	0	2/10 (20%)	39	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Injection site reaction	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/51 (2%)	4	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	2/50 (4%)	6	0/34 (0%)	0	2/21 (9.5%)	4	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Pyrexia	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	2/50 (4%)	2	2/34 (5.9%)	2	1/21 (4.8%)	2	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Hepatobiliary disorders
Cholelithiasis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	2	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Hyperplastic cholecystopathy	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Infections and infestations
Appendicitis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Body tinea	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	3/34 (8.8%)	3	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Bronchitis	1/52 (1.9%)	1	1/51 (2%)	1	1/51 (2%)	1	0/51 (0%)	0	0/15 (0%)	0	1/30 (3.3%)	1	0/34 (0%)	0	0/50 (0%)	0	1/34 (2.9%)	1	2/21 (9.5%)	2	3/15 (20%)	4	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Conjunctivitis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	1/30 (3.3%)	2	0/34 (0%)	0	0/50 (0%)	0	2/34 (5.9%)	2	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Ear infection	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/2 (0%)	0
Erythema migrans	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Gastroenteritis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	1/34 (2.9%)	1	3/21 (14.3%)	3	1/15 (6.7%)	1	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Gastrointestinal infection	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	1/21 (4.8%)	1	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Helicobacter infection	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Hepatitis a	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Hepatitis e	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Influenza	0/52 (0%)	0	0/51 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	0/15 (0%)	0	1/30 (3.3%)	1	2/34 (5.9%)	2	3/50 (6%)	3	2/34 (5.9%)	2	1/21 (4.8%)	1	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	1/2 (50%)	1
Localised infection	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Nasopharyngitis	7/52 (13.5%)	8	5/51 (9.8%)	7	6/51 (11.8%)	8	8/51 (15.7%)	10	3/15 (20%)	8	3/30 (10%)	3	7/34 (20.6%)	10	15/50 (30%)	26	12/34 (35.3%)	25	5/21 (23.8%)	13	5/15 (33.3%)	12	2/10 (20%)	3	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Oral herpes	0/52 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	1/34 (2.9%)	1	2/50 (4%)	2	1/34 (2.9%)	1	1/21 (4.8%)	1	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Otitis externa	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	2	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	1/10 (10%)	2	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Pharyngitis	0/52 (0%)	0	2/51 (3.9%)	3	0/51 (0%)	0	1/51 (2%)	1	1/15 (6.7%)	1	1/30 (3.3%)	1	0/34 (0%)	0	2/50 (4%)	2	3/34 (8.8%)	3	3/21 (14.3%)	3	2/15 (13.3%)	2	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Pneumonia	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	1	0/34 (0%)	0	1/21 (4.8%)	1	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	1/6 (16.7%)	1	0/2 (0%)	0
Pulpitis dental	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	2	0/34 (0%)	0	1/21 (4.8%)	1	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Respiratory tract infection	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	1/21 (4.8%)	1	0/15 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Sinusitis	0/52 (0%)	0	1/51 (2%)	1	1/51 (2%)	1	0/51 (0%)	0	1/15 (6.7%)	1	1/30 (3.3%)	1	1/34 (2.9%)	2	1/50 (2%)	1	1/34 (2.9%)	1	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Skin infection	1/52 (1.9%)	1	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Tinea pedis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/51 (2%)	1	0/15 (0%)	0	0/30 (0%)	0	1/34 (2.9%)	1	0/50 (0%)	0	2/34 (5.9%)	2	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Tooth infection	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	1/30 (3.3%)	1	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	1/21 (4.8%)	1	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Upper respiratory tract infection	2/52 (3.8%)	2	6/51 (11.8%)	6	3/51 (5.9%)	3	2/51 (3.9%)	3	2/15 (13.3%)	2	5/30 (16.7%)	6	2/34 (5.9%)	2	8/50 (16%)	9	3/34 (8.8%)	7	5/21 (23.8%)	6	1/15 (6.7%)	2	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Urethritis chlamydial	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Urinary tract infection	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	3/34 (8.8%)	3	4/50 (8%)	5	1/34 (2.9%)	1	1/21 (4.8%)	2	2/15 (13.3%)	3	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Viral upper respiratory tract infection	0/52 (0%)	0	0/51 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	0/15 (0%)	0	1/30 (3.3%)	1	0/34 (0%)	0	1/50 (2%)	1	0/34 (0%)	0	1/21 (4.8%)	1	0/15 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Vulvovaginal candidiasis	0/10 (0%)	0	0/12 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	1/8 (12.5%)	1	0/10 (0%)	0	0/8 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/2 (0%)	0	0/0 (NaN)	0	0/1 (0%)	0	0/1 (0%)	0	0/0 (NaN)	0	0/3 (0%)	0	0/1 (0%)	0
Wound infection	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Injury, poisoning and procedural complications
Facial bones fracture	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Humerus fracture	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Limb injury	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	3/50 (6%)	3	0/34 (0%)	0	1/21 (4.8%)	1	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Maternal exposure during pregnancy	0/10 (0%)	0	0/12 (0%)	0	0/16 (0%)	0	1/15 (6.7%)	1	0/4 (0%)	0	1/10 (10%)	1	0/8 (0%)	0	0/10 (0%)	0	0/8 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/2 (0%)	0	0/0 (NaN)	0	0/1 (0%)	0	0/1 (0%)	0	0/0 (NaN)	0	0/3 (0%)	0	0/1 (0%)	0
Muscle strain	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	1/30 (3.3%)	1	0/34 (0%)	0	2/50 (4%)	2	2/34 (5.9%)	2	1/21 (4.8%)	1	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Procedural pain	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	1/30 (3.3%)	2	1/34 (2.9%)	1	0/50 (0%)	0	0/34 (0%)	0	1/21 (4.8%)	1	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Rib fracture	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	1	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Skin laceration	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	1/34 (2.9%)	1	2/50 (4%)	2	1/34 (2.9%)	1	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Tooth fracture	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/51 (2%)	1	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	3/34 (8.8%)	4	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Investigations
Alanine aminotransferase increased	0/52 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	7	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Aspartate aminotransferase increased	0/52 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	5	0/30 (0%)	0	1/34 (2.9%)	1	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Blood creatine phosphokinase increased	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	2	2/34 (5.9%)	5	3/21 (14.3%)	5	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Electrocardiogram qt prolonged	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	2	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Weight increased	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	1/34 (2.9%)	1	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Metabolism and nutrition disorders
Diabetes mellitus	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	1/30 (3.3%)	1	2/34 (5.9%)	2	1/50 (2%)	1	1/34 (2.9%)	1	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Hypercholesterolaemia	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	1	1/34 (2.9%)	1	1/21 (4.8%)	1	0/15 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Hypertriglyceridaemia	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	1	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Obesity	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	1/34 (2.9%)	1	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Type 2 diabetes mellitus	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	2/30 (6.7%)	2	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/52 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	1/51 (2%)	1	0/15 (0%)	0	0/30 (0%)	0	3/34 (8.8%)	3	1/50 (2%)	4	2/34 (5.9%)	2	3/21 (14.3%)	4	1/15 (6.7%)	1	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Arthritis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	1/21 (4.8%)	1	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Back pain	1/52 (1.9%)	1	1/51 (2%)	1	1/51 (2%)	1	0/51 (0%)	0	1/15 (6.7%)	1	1/30 (3.3%)	1	0/34 (0%)	0	3/50 (6%)	3	8/34 (23.5%)	10	3/21 (14.3%)	4	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Exostosis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Joint swelling	1/52 (1.9%)	1	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	2/34 (5.9%)	2	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Muscle spasms	0/52 (0%)	0	1/51 (2%)	1	1/51 (2%)	1	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Muscle tightness	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	2	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Musculoskeletal pain	0/52 (0%)	0	1/51 (2%)	2	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	2/34 (5.9%)	2	1/50 (2%)	1	2/34 (5.9%)	2	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Pain in extremity	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/51 (2%)	1	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	1	0/34 (0%)	0	2/21 (9.5%)	2	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Psoriatic arthropathy	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	2/50 (4%)	3	1/34 (2.9%)	1	1/21 (4.8%)	1	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Tenosynovitis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	1/34 (2.9%)	1	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	1/30 (3.3%)	1	0/34 (0%)	0	1/50 (2%)	1	2/34 (5.9%)	2	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	1/4 (25%)	1	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Nervous system disorders
Headache	1/52 (1.9%)	1	1/51 (2%)	1	2/51 (3.9%)	2	1/51 (2%)	1	1/15 (6.7%)	1	2/30 (6.7%)	5	3/34 (8.8%)	3	3/50 (6%)	4	2/34 (5.9%)	4	2/21 (9.5%)	2	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Psychiatric disorders
Anxiety	0/52 (0%)	0	0/51 (0%)	0	1/51 (2%)	1	1/51 (2%)	1	0/15 (0%)	0	0/30 (0%)	0	2/34 (5.9%)	2	0/50 (0%)	0	0/34 (0%)	0	1/21 (4.8%)	1	0/15 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Renal and urinary disorders
Haematuria	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	2/34 (5.9%)	2	1/50 (2%)	1	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Pollakiuria	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Proteinuria	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Reproductive system and breast disorders
Dysmenorrhoea	0/10 (0%)	0	0/12 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/8 (0%)	0	0/10 (0%)	0	0/8 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/2 (0%)	0	0/0 (NaN)	0	0/1 (0%)	0	0/1 (0%)	0	0/0 (NaN)	0	0/3 (0%)	0	0/1 (0%)	0
Menorrhagia	0/10 (0%)	0	0/12 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/8 (0%)	0	1/10 (10%)	1	0/8 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/2 (0%)	0	0/0 (NaN)	0	0/1 (0%)	0	0/1 (0%)	0	0/0 (NaN)	0	0/3 (0%)	0	0/1 (0%)	0
Ovarian cyst	0/10 (0%)	0	0/12 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/4 (0%)	0	0/10 (0%)	0	0/8 (0%)	0	1/10 (10%)	1	0/8 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/2 (0%)	0	0/0 (NaN)	0	0/1 (0%)	0	0/1 (0%)	0	0/0 (NaN)	0	0/3 (0%)	0	0/1 (0%)	0
Prostatomegaly	0/42 (0%)	0	0/39 (0%)	0	0/35 (0%)	0	0/36 (0%)	0	0/11 (0%)	0	0/20 (0%)	0	0/26 (0%)	0	0/40 (0%)	0	0/26 (0%)	0	0/15 (0%)	0	1/9 (11.1%)	1	0/8 (0%)	0	0/2 (0%)	0	0/3 (0%)	0	0/2 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Scrotal pain	0/42 (0%)	0	0/39 (0%)	0	0/35 (0%)	0	0/36 (0%)	0	0/11 (0%)	0	0/20 (0%)	0	0/26 (0%)	0	0/40 (0%)	0	0/26 (0%)	0	1/15 (6.7%)	1	0/9 (0%)	0	0/8 (0%)	0	0/2 (0%)	0	0/3 (0%)	0	0/2 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Vaginal haemorrhage	0/10 (0%)	0	0/12 (0%)	0	0/16 (0%)	0	0/15 (0%)	0	0/4 (0%)	0	1/10 (10%)	1	0/8 (0%)	0	0/10 (0%)	0	0/8 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/2 (0%)	0	0/0 (NaN)	0	0/1 (0%)	0	0/1 (0%)	0	0/0 (NaN)	0	0/3 (0%)	0	0/1 (0%)	0
Vulvovaginal pruritus	0/10 (0%)	0	0/12 (0%)	0	0/16 (0%)	0	1/15 (6.7%)	1	0/4 (0%)	0	0/10 (0%)	0	0/8 (0%)	0	0/10 (0%)	0	0/8 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/2 (0%)	0	0/0 (NaN)	0	0/1 (0%)	0	0/1 (0%)	0	0/0 (NaN)	0	0/3 (0%)	0	0/1 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	2/34 (5.9%)	2	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Cough	1/52 (1.9%)	1	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	2/30 (6.7%)	2	2/34 (5.9%)	2	0/50 (0%)	0	5/34 (14.7%)	8	1/21 (4.8%)	1	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Dyspnoea	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	1/34 (2.9%)	1	2/21 (9.5%)	2	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Oropharyngeal pain	0/52 (0%)	0	0/51 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	2/15 (13.3%)	2	1/30 (3.3%)	1	1/34 (2.9%)	1	3/50 (6%)	3	2/34 (5.9%)	2	2/21 (9.5%)	2	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Rhinitis allergic	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	1/30 (3.3%)	1	0/34 (0%)	0	1/50 (2%)	1	1/34 (2.9%)	1	1/21 (4.8%)	1	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Sinus congestion	0/52 (0%)	0	0/51 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	1/15 (6.7%)	1	1/30 (3.3%)	1	2/34 (5.9%)	2	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Upper respiratory tract congestion	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis	0/52 (0%)	0	1/51 (2%)	1	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	2/34 (5.9%)	2	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Onycholysis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Pruritus	2/52 (3.8%)	2	1/51 (2%)	1	1/51 (2%)	1	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	3/50 (6%)	3	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Psoriasis	1/52 (1.9%)	1	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	2	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Stasis dermatitis	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Urticaria	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/51 (2%)	1	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	1/34 (2.9%)	1	0/21 (0%)	0	0/15 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Surgical and medical procedures
Cataract operation	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/15 (0%)	0	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	1/10 (10%)	1	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Sinus operation	0/52 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	0/50 (0%)	0	0/34 (0%)	0	0/21 (0%)	0	0/15 (0%)	0	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Tooth extraction	2/52 (3.8%)	2	1/51 (2%)	1	0/51 (0%)	0	0/51 (0%)	0	1/15 (6.7%)	1	0/30 (0%)	0	0/34 (0%)	0	1/50 (2%)	1	1/34 (2.9%)	1	0/21 (0%)	0	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0
Vascular disorders
Hypertension	0/52 (0%)	0	0/51 (0%)	0	3/51 (5.9%)	3	3/51 (5.9%)	3	0/15 (0%)	0	3/30 (10%)	3	3/34 (8.8%)	4	4/50 (8%)	4	3/34 (8.8%)	3	5/21 (23.8%)	5	1/15 (6.7%)	1	0/10 (0%)	0	0/2 (0%)	0	0/4 (0%)	0	0/3 (0%)	0	0/3 (0%)	0	0/6 (0%)	0	0/2 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.