Trial Outcomes & Findings for A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis (NCT NCT02589665)
NCT ID: NCT02589665
Last Updated: 2020-06-17
Results Overview
Clinical remission at week 12 is a defined as achieving a 9-pt Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1, excluding Physician's Global Assessment (PGA). * Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); * Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); * Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); * Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from 0 (normal) to 3 (severe disease). The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
249 participants
Primary outcome timeframe
Week 12
Results posted on
2020-06-17
Participant Flow
Participant milestones
| Measure |
Induction: 200 mg Mirikizumab IV Q4W
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Induction: 600 mg Mirikizumab IV Q4W
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Maintenance: Placebo SC Q4W
Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
|
Maintenance: 200 mg Mirikizumab SC Q4W
Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
|
Maintenance: 200 mg Mirikizumab SC Q12W
Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
Induction Extension: 600mg Mirikizumab IV Q4W
Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
|
Induction Extension: 1000mg Mirikizumab IV Q4W
Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
|
Maintenance Extension: 200mg Mirikizumab SC Q4W
Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label.
|
Induction: Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
|
Induction: 50 mg Mirikizumab IV Q4W
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Period
STARTED
|
62
|
61
|
0
|
0
|
0
|
0
|
0
|
0
|
63
|
63
|
|
Induction Period
Received at Least One Dose of Study Drug
|
62
|
60
|
0
|
0
|
0
|
0
|
0
|
0
|
63
|
63
|
|
Induction Period
COMPLETED
|
60
|
57
|
0
|
0
|
0
|
0
|
0
|
0
|
60
|
61
|
|
Induction Period
NOT COMPLETED
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
2
|
|
Maintenance Period
STARTED
|
0
|
0
|
13
|
47
|
46
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
NOT COMPLETED
|
0
|
0
|
13
|
47
|
46
|
0
|
0
|
0
|
0
|
0
|
|
Induction Extension Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
32
|
96
|
0
|
0
|
0
|
|
Induction Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
30
|
84
|
0
|
0
|
0
|
|
Induction Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
12
|
0
|
0
|
0
|
|
Maintenance Extension Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
68
|
0
|
0
|
|
Maintenance Extension Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Extension Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
68
|
0
|
0
|
Reasons for withdrawal
| Measure |
Induction: 200 mg Mirikizumab IV Q4W
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Induction: 600 mg Mirikizumab IV Q4W
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Maintenance: Placebo SC Q4W
Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
|
Maintenance: 200 mg Mirikizumab SC Q4W
Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
|
Maintenance: 200 mg Mirikizumab SC Q12W
Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
Induction Extension: 600mg Mirikizumab IV Q4W
Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
|
Induction Extension: 1000mg Mirikizumab IV Q4W
Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
|
Maintenance Extension: 200mg Mirikizumab SC Q4W
Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label.
|
Induction: Placebo IV Q4W
Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
|
Induction: 50 mg Mirikizumab IV Q4W
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Induction Period
Did not receive drug
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Period
Adverse Event
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Induction Period
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Induction Period
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Maintenance Period
Rolled Over to Study AMAP (NCT03519945)
|
0
|
0
|
7
|
41
|
39
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Withdrawal by Subject
|
0
|
0
|
4
|
2
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Lack of Efficacy
|
0
|
0
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Reason Not Collected
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Induction Extension Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
|
Induction Extension Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Induction Extension Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
0
|
0
|
0
|
|
Induction Extension Period
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Induction Extension Period
Reason Not Collected
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Extension Period
Rolled Over to Study AMAP (NCT03519945)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
57
|
0
|
0
|
|
Maintenance Extension Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Maintenance Extension Period
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Maintenance Extension Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Maintenance Extension Period
Non-responder
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Induction: Placebo IV Q4W
n=63 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
Induction: 50 mg Mirikizumab IV Q4W
n=63 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Induction: 200 mg Mirikizumab IV Q4W
n=62 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Induction: 600 mg Mirikizumab IV Q4W
n=61 Participants
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.62 years
STANDARD_DEVIATION 13.47 • n=99 Participants
|
41.83 years
STANDARD_DEVIATION 14.06 • n=107 Participants
|
43.35 years
STANDARD_DEVIATION 14.75 • n=206 Participants
|
42.44 years
STANDARD_DEVIATION 13.371 • n=7 Participants
|
42.56 years
STANDARD_DEVIATION 13.85 • n=31 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
100 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
149 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
231 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
56 Participants
n=7 Participants
|
209 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Hungary
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Region of Enrollment
Czechia
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Region of Enrollment
Japan
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Region of Enrollment
Moldova
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
|
Region of Enrollment
Denmark
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
Poland
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
49 Participants
n=31 Participants
|
|
Region of Enrollment
Georgia
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Region of Enrollment
Lithuania
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Region of Enrollment
Australia
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Induction Period: All randomized participants.
Clinical remission at week 12 is a defined as achieving a 9-pt Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1, excluding Physician's Global Assessment (PGA). * Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); * Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); * Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); * Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from 0 (normal) to 3 (severe disease). The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
Outcome measures
| Measure |
Placebo IV Q4W
n=63 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=63 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=62 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
n=61 Participants
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Induction Period: Percentage of Participants With Clinical Remission at Week 12
|
4.8 percentage of participants
Interval 0.0 to 10.0
|
15.9 percentage of participants
Interval 6.8 to 24.9
|
22.6 percentage of participants
Interval 12.2 to 33.0
|
11.5 percentage of participants
Interval 3.5 to 19.5
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Induction Period: All randomized participants.
Clinical response at week 12 is defined as a decrease in the 9-point Mayo subscores (rectal bleeding, stool frequency and the endoscopic findings) inclusive of \>= 2 points and \>=35% from baseline with either a decrease of rectal bleeding subscore of \>=1 or rectal bleeding subscore of 0 or 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores: * Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); * Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); * Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
Outcome measures
| Measure |
Placebo IV Q4W
n=63 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=63 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=62 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
n=61 Participants
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Induction Period: Percentage of Participants With Clinical Response at Week 12
|
20.6 percentage of participants
Interval 10.6 to 30.6
|
41.3 percentage of participants
Interval 29.1 to 53.4
|
59.7 percentage of participants
Interval 47.5 to 71.9
|
49.2 percentage of participants
Interval 36.6 to 61.7
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Induction Period: All randomized participants.
Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic score of 0 at Week 12. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The total score ranges from 0 to 3 points, with higher scores representing more severe disease.
Outcome measures
| Measure |
Placebo IV Q4W
n=63 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=63 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=62 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
n=61 Participants
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Induction Period: Percentage of Participants With Endoscopic Remission at Week 12
|
1.6 percentage of participants
Interval 0.0 to 4.7
|
3.2 percentage of participants
Interval 0.0 to 7.5
|
3.2 percentage of participants
Interval 0.0 to 7.6
|
1.6 percentage of participants
Interval 0.0 to 4.8
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Maintenance period: All randomized participants in maintenance period.
Endoscopic remission at week 52 is defined as achieving a Mayo endoscopic subscore of 0 at Week 52. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); The total score ranges from 0 to 3 points, with higher scores representing more severe disease.
Outcome measures
| Measure |
Placebo IV Q4W
n=13 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=47 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=46 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Maintenance Period: Percentage of Participants With Endoscopic Remission at Week 52
|
7.7 percentage of participants
Interval 0.0 to 22.2
|
14.9 percentage of participants
Interval 4.7 to 25.1
|
28.3 percentage of participants
Interval 15.2 to 41.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Induction Period: All randomized participants who had a baseline and at least one post-baseline IBDQ value.
The IBDQ is a 32-item subject-completed questionnaire that measures 4 aspects of subjects' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function (Guyatt et al. 1989). Responses are graded on a 7-point. Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." Scores range from 32 to 224; a higher score indicates a better quality of life. LS Mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Placebo IV Q4W
n=60 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=60 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=60 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
n=56 Participants
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Induction Period: Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
|
22.3 score on a scale
Standard Error 4.41
|
33.0 score on a scale
Standard Error 4.52
|
42.8 score on a scale
Standard Error 4.40
|
45.2 score on a scale
Standard Error 4.54
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Induction Period: All randomized participants who had a baseline and at least one post-baseline SF-36 value.
SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, with higher values representing a better outcome \[(Raw score) - min{raw score}\] / (max {raw score} - min{raw score}) x 100\]. LS Mean was calculated using Mixed effect Model Repeat Measurement (MMRM) model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Placebo IV Q4W
n=60 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=60 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=60 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
n=56 Participants
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
Mental Health
|
1.9 score on a scale
Standard Error 1.18
|
3.7 score on a scale
Standard Error 1.22
|
6.4 score on a scale
Standard Error 1.17
|
7.6 score on a scale
Standard Error 1.21
|
—
|
|
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
Physical Component Score
|
3.4 score on a scale
Standard Error 0.83
|
6.2 score on a scale
Standard Error 0.86
|
5.9 score on a scale
Standard Error 0.83
|
6.9 score on a scale
Standard Error 0.85
|
—
|
|
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
Mental Component Score
|
3.2 score on a scale
Standard Error 1.22
|
4.5 score on a scale
Standard Error 1.26
|
6.8 score on a scale
Standard Error 1.20
|
8.8 score on a scale
Standard Error 1.25
|
—
|
|
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
Physical Functioning
|
2.1 score on a scale
Standard Error 0.76
|
3.7 score on a scale
Standard Error 0.78
|
4.6 score on a scale
Standard Error 0.74
|
6.2 score on a scale
Standard Error 0.77
|
—
|
|
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
Role-Physical
|
4.5 score on a scale
Standard Error 1.19
|
7.5 score on a scale
Standard Error 1.22
|
7.2 score on a scale
Standard Error 1.17
|
8.0 score on a scale
Standard Error 1.22
|
—
|
|
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
Bodily Pain
|
3.7 score on a scale
Standard Error 1.15
|
7.9 score on a scale
Standard Error 1.18
|
8.9 score on a scale
Standard Error 1.14
|
10.0 score on a scale
Standard Error 1.18
|
—
|
|
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
General Health
|
3.1 score on a scale
Standard Error 0.93
|
3.8 score on a scale
Standard Error 0.96
|
4.3 score on a scale
Standard Error 0.92
|
5.1 score on a scale
Standard Error 0.96
|
—
|
|
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
Vitality
|
3.3 score on a scale
Standard Error 1.25
|
6.5 score on a scale
Standard Error 1.28
|
7.5 score on a scale
Standard Error 1.23
|
9.7 score on a scale
Standard Error 1.28
|
—
|
|
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
Social Functioning
|
6.5 score on a scale
Standard Error 1.22
|
8.0 score on a scale
Standard Error 1.26
|
9.4 score on a scale
Standard Error 1.21
|
11.6 score on a scale
Standard Error 1.26
|
—
|
|
Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
Role-Emotional
|
3.0 score on a scale
Standard Error 1.22
|
3.7 score on a scale
Standard Error 1.26
|
5.5 score on a scale
Standard Error 1.20
|
7.6 score on a scale
Standard Error 1.25
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Induction Period: All randomized participants who had a baseline and at least one post-baseline PGI-S value.
PGI-S is a 1-item subject-rated questionnaire designed to assess the subject's impression of their disease symptoms at baseline (Guy 1976; Yalcin and Bump 2003). Responses are graded on a 7-point scale in which a score of 1 indicates that the subject's symptom(s) are "normal," a score of 2 indicates that the subject feels "borderline ill," a score of 3 indicates that the subject feels "mildly ill," a score of 4 indicates that the subject(s) feel "moderately ill," and scores of 5, 6, and 7 indicate that the subject feels "markedly ill," "severely ill," and "extremely ill," respectively. LS Mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Placebo IV Q4W
n=60 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=60 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=60 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
n=56 Participants
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Induction Period: Change From Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score
|
-0.84 score on a scale
Standard Error 0.19
|
-1.43 score on a scale
Standard Error 0.20
|
-1.90 score on a scale
Standard Error 0.18
|
-1.74 score on a scale
Standard Error 0.19
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Induction Period: All randomized participants who had a baseline and at least one post-baseline PGI-I value.
PGI-I scale is a subject-rated instrument designed to assess the subject's impression of change in their symptom(s) (Guy 1976; Yalcin and Bump 2003). Responses are graded on a 7-point Likert scale in which a score of 1 indicates that the subject's symptom(s) is "very much better," a score of 4 indicates that the subject's symptom(s) has experienced "no change," and a score of 7 indicates that the subject's symptom(s) is "very much worse."
Outcome measures
| Measure |
Placebo IV Q4W
n=63 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=62 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=61 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
n=60 Participants
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12
|
3.37 score on a scale
Standard Deviation 1.46
|
2.69 score on a scale
Standard Deviation 1.31
|
2.39 score on a scale
Standard Deviation 0.99
|
2.53 score on a scale
Standard Deviation 1.16
|
—
|
SECONDARY outcome
Timeframe: Induction Period: Day (D) 1, D15 ± 2d, D29 ± 2d, D43 ± 2d, D57 ± 2d, D78-85; Maintenance Period: D85-92,D113± 7d,D141± 7d,D169± 7d,D225 ±7d,D281 ±7d,D337 ±7d,D393± 7d,D448± 7d,D504± 7d,D560± 7d,D616± 7d,D672± 7d,D728± 7d,D784± 7d,D840± 7dPopulation: All participants who received at least one dose of mirikizumab in the induction and maintenance period who had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, tau) of Mirikizumab
Outcome measures
| Measure |
Placebo IV Q4W
n=63 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=62 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=61 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
n=47 Participants
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
n=46 Participants
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, Tau) of Mirikizumab
|
3330 Microgram*hour/milligram(ug*hr/ml)
Geometric Coefficient of Variation 42.5
|
10100 Microgram*hour/milligram(ug*hr/ml)
Geometric Coefficient of Variation 35.0
|
24900 Microgram*hour/milligram(ug*hr/ml)
Geometric Coefficient of Variation 36.6
|
3700 Microgram*hour/milligram(ug*hr/ml)
Geometric Coefficient of Variation 41.5
|
1270 Microgram*hour/milligram(ug*hr/ml)
Geometric Coefficient of Variation 42.3
|
SECONDARY outcome
Timeframe: Week 12Population: Induction Period: All randomized participants.
Symptomatic remission is defined as a stool frequency score of 0 or 1 and a rectal bleeding score of 0. * Stool Frequency Subscore is based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal). * Rectal Bleeding Subscore is based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed). The total score ranges from 0 to 1 points, with higher scores representing more severe disease. The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
Outcome measures
| Measure |
Placebo IV Q4W
n=63 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=63 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=62 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
n=61 Participants
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Induction Period: Percentage of Participants With Symptomatic Remission at Week 12
|
20.6 percentage of participants
Interval 10.6 to 30.6
|
36.5 percentage of participants
Interval 24.6 to 48.4
|
58.1 percentage of participants
Interval 45.8 to 70.3
|
45.9 percentage of participants
Interval 33.4 to 58.4
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Maintenance period: All randomized participants in maintenance period.
Symptomatic remission is defined as a stool frequency score of 0 or 1 and a rectal bleeding score of 0. * Stool Frequency Subscore , based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); * Rectal Bleeding Subscore , based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); * Endoscopy Subscore , based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration); * Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from zero (normal) to 3 (severe disease). The total score ranges from 0 to 1 points, with higher scores representing more severe disease. The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
Outcome measures
| Measure |
Placebo IV Q4W
n=13 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=47 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=46 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52
|
53.8 Percentage of Participants
Interval 26.7 to 80.9
|
76.6 Percentage of Participants
Interval 64.5 to 88.7
|
65.2 Percentage of Participants
Interval 51.5 to 79.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Induction Period: All randomized participants.
Endoscopic Improvement defined as achieving an endoscopic findings subscore of 0 or 1. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
Outcome measures
| Measure |
Placebo IV Q4W
n=63 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=63 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=62 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
n=61 Participants
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12
|
6.3 percentage of participants
Interval 0.3 to 12.4
|
23.8 percentage of participants
Interval 13.3 to 34.3
|
30.6 percentage of participants
Interval 19.2 to 42.1
|
13.1 percentage of participants
Interval 4.6 to 21.6
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Maintenance period: All randomized participants in maintenance period.
Endoscopic Improvement defined as achieving an endoscopic findings subscore of 0 or 1. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
Outcome measures
| Measure |
Placebo IV Q4W
n=13 Participants
Placebo administered every 4 weeks (Q4W) intravenously (IV).
|
50 mg Mirikizumab IV Q4W
n=47 Participants
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab IV Q4W
n=46 Participants
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
600 mg Mirikizumab IV Q4W
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV).
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
200 mg Mirikizumab SC Q12W
200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
|---|---|---|---|---|---|
|
Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52
|
15.4 Percentage of Participants
Interval 0.0 to 35.0
|
57.4 Percentage of Participants
Interval 43.3 to 71.6
|
47.8 Percentage of Participants
Interval 33.4 to 62.3
|
—
|
—
|
Adverse Events
Induction: Placebo IV Q4W
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Induction: 50 mg Mirikizumab Administered Every 4 Weeks (Q4W)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Induction: 200 mg Mirikizumab IV Q4W
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Induction: 600 mg Mirikizumab IV Q4W
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Maintenance: Placebo SC Q4W
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Maintenance: 200 mg Mirikizumab SC Q4W
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Maintenance: 200 mg Mirikizumab SC Q12W
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Induction Extension: 600mg Mirikizumab IV Q4W
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Induction Extension:1000mg Mirikizumab IV Q4W
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Maintenance Extension: 200mg Mirikizumab SC Q4W
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction: Placebo IV Q4W
n=63 participants at risk
Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
|
Induction: 50 mg Mirikizumab Administered Every 4 Weeks (Q4W)
n=63 participants at risk
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Induction: 200 mg Mirikizumab IV Q4W
n=62 participants at risk
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Induction: 600 mg Mirikizumab IV Q4W
n=60 participants at risk
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Maintenance: Placebo SC Q4W
n=13 participants at risk
Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
|
Maintenance: 200 mg Mirikizumab SC Q4W
n=47 participants at risk
Induction mirikizumab responders: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
|
Maintenance: 200 mg Mirikizumab SC Q12W
n=46 participants at risk
Induction mirikizumab responders: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
Induction Extension: 600mg Mirikizumab IV Q4W
n=32 participants at risk
Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
|
Induction Extension:1000mg Mirikizumab IV Q4W
n=96 participants at risk
Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) ) once every 4 weeks (Q4W) during the Extension Open-Label.
|
Maintenance Extension: 200mg Mirikizumab SC Q4W
n=68 participants at risk
Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
2/96 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.6%
1/63 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.6%
1/63 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Platelet count increased
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/96 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/96 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.1%
1/32 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
2/96 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Induction: Placebo IV Q4W
n=63 participants at risk
Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
|
Induction: 50 mg Mirikizumab Administered Every 4 Weeks (Q4W)
n=63 participants at risk
50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Induction: 200 mg Mirikizumab IV Q4W
n=62 participants at risk
200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Induction: 600 mg Mirikizumab IV Q4W
n=60 participants at risk
600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
|
Maintenance: Placebo SC Q4W
n=13 participants at risk
Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
|
Maintenance: 200 mg Mirikizumab SC Q4W
n=47 participants at risk
Induction mirikizumab responders: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
|
Maintenance: 200 mg Mirikizumab SC Q12W
n=46 participants at risk
Induction mirikizumab responders: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
|
Induction Extension: 600mg Mirikizumab IV Q4W
n=32 participants at risk
Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
|
Induction Extension:1000mg Mirikizumab IV Q4W
n=96 participants at risk
Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) ) once every 4 weeks (Q4W) during the Extension Open-Label.
|
Maintenance Extension: 200mg Mirikizumab SC Q4W
n=68 participants at risk
Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.2%
2/32 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.0%
1/96 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.5%
4/47 • Number of events 4 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/27 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/20 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/33 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.3%
4/63 • Number of events 4 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.3%
2/60 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
3/63 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.3%
4/63 • Number of events 4 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.3%
2/60 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/47 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
4/68 • Number of events 4 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
9.5%
6/63 • Number of events 6 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
2/63 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.7%
1/60 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
53.8%
7/13 • Number of events 10 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.5%
4/47 • Number of events 4 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.2%
7/46 • Number of events 7 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.3%
7/68 • Number of events 7 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
3/47 • Number of events 5 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
6.3%
4/63 • Number of events 5 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
2/63 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
2/62 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.0%
3/60 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
3/47 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
3/46 • Number of events 6 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site pain
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
3/47 • Number of events 14 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/46 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Injection site reaction
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
3/47 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.5%
4/47 • Number of events 4 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.4%
2/13 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.4%
3/47 • Number of events 5 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
4/46 • Number of events 5 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.4%
3/32 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
6/63 • Number of events 7 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.9%
5/63 • Number of events 5 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
3/62 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.3%
5/60 • Number of events 5 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.8%
6/47 • Number of events 12 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
17.4%
8/46 • Number of events 10 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.6%
5/32 • Number of events 5 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.3%
7/96 • Number of events 8 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
20.6%
14/68 • Number of events 21 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.3%
2/47 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
3/46 • Number of events 4 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.7%
4/46 • Number of events 5 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
4/68 • Number of events 8 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 7 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.6%
5/47 • Number of events 7 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.8%
6/68 • Number of events 7 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
3/46 • Number of events 4 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Vitamin b12 decreased
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Vitamin d decreased
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Weight increased
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
12.8%
6/47 • Number of events 9 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
1/46 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
23.1%
3/13 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.8%
6/68 • Number of events 7 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/13 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/47 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
5/68 • Number of events 5 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/62 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/60 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
1/47 • Number of events 2 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/46 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
4.8%
3/63 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
3/63 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/62 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.7%
4/60 • Number of events 5 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.7%
1/13 • Number of events 1 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.6%
5/47 • Number of events 9 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.5%
3/46 • Number of events 3 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/32 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/96 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Up To 39 Months
All participants who received at least one dose of study. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60