Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis (NCT NCT03559270)
NCT ID: NCT03559270
Last Updated: 2022-11-08
Results Overview
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
374 participants
Primary outcome timeframe
Week 16
Results posted on
2022-11-08
Participant Flow
Eligible participants (nonresponder/partial responder: completed at least 16 weeks of treatment; responder: completed the full treatment period) from originating study JAIW (NCT03435081) enrolled into Open-label Treatment Period of JAIX \[lasting from Week 0 (baseline through Week 200) or early termination visit\]. Participants enrolled directly into Protocol Addendum I4V-MC-JAIX (2) without first completing at least 16 weeks of treatment in originating study JAIW.
Participant milestones
| Measure |
Placebo/Baricitinib 2-milligram (mg)
Open-label 2 mg baricitinib administered orally once daily (QD) to participants who randomized to placebo in the originating study (JAIW).
|
Baricitinib 1-mg/Baricitinib 2-mg
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg/Baricitinib 2-mg
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg Open-Label Addendum
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
117
|
119
|
108
|
30
|
|
Overall Study
Received at Least One Dose of Study Drug
|
117
|
119
|
108
|
30
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
117
|
118
|
108
|
30
|
Reasons for withdrawal
| Measure |
Placebo/Baricitinib 2-milligram (mg)
Open-label 2 mg baricitinib administered orally once daily (QD) to participants who randomized to placebo in the originating study (JAIW).
|
Baricitinib 1-mg/Baricitinib 2-mg
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg/Baricitinib 2-mg
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg Open-Label Addendum
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
34
|
52
|
37
|
2
|
|
Overall Study
Death
|
0
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
16
|
4
|
12
|
3
|
|
Overall Study
Sponsor Decision
|
38
|
31
|
35
|
18
|
|
Overall Study
Withdrawal by Subject
|
19
|
21
|
18
|
7
|
|
Overall Study
Physician Decision
|
3
|
2
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
0
|
Baseline Characteristics
A Study of Baricitinib (LY3009104) in Participants With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Placebo/Baricitinib 2-mg
n=117 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to placebo in the originating study (JAIW).
|
Baricitinib 1-mg/Baricitinib 2-mg
n=119 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg/Baricitinib 2-mg
n=108 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg Open-Label Addendum
n=30 Participants
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
|
Total
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.90 years
STANDARD_DEVIATION 16.87 • n=5 Participants
|
40.70 years
STANDARD_DEVIATION 16.86 • n=7 Participants
|
39.30 years
STANDARD_DEVIATION 15.05 • n=5 Participants
|
43.80 years
STANDARD_DEVIATION 17.67 • n=4 Participants
|
40.30 years
STANDARD_DEVIATION 16.41 • n=21 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
188 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
186 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
309 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
215 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
36 participants
n=5 Participants
|
38 participants
n=7 Participants
|
31 participants
n=5 Participants
|
0 participants
n=4 Participants
|
105 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=5 Participants
|
81 participants
n=7 Participants
|
77 participants
n=5 Participants
|
30 participants
n=4 Participants
|
269 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: mITT population included all participants who received at least one dose of study drug.
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as EASI75.
Outcome measures
| Measure |
Placebo/Baricitinib 2-mg
n=117 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to placebo in the originating study (JAIW).
|
Baricitinib 1-mg/Baricitinib 2-mg
n=119 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg/Baricitinib 2-mg
n=108 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg Open-Label Addendum
n=30 Participants
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)
|
59.0 percentage of participants
|
40.3 percentage of participants
|
45.4 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: mITT population included all participants who received at least one dose of study drug.
The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1.
Outcome measures
| Measure |
Placebo/Baricitinib 2-mg
n=117 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to placebo in the originating study (JAIW).
|
Baricitinib 1-mg/Baricitinib 2-mg
n=119 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg/Baricitinib 2-mg
n=108 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg Open-Label Addendum
n=30 Participants
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1
|
44.4 percentage of participants
|
18.5 percentage of participants
|
29.6 percentage of participants
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: mITT population included all participants who received at least one dose of study drug.
The BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). Percent of BSA for a body region was calculated as = total number of palms in a body region \* % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values representing greater severity of AD.
Outcome measures
| Measure |
Placebo/Baricitinib 2-mg
n=117 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to placebo in the originating study (JAIW).
|
Baricitinib 1-mg/Baricitinib 2-mg
n=119 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg/Baricitinib 2-mg
n=108 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg Open-Label Addendum
n=30 Participants
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a Body Surface Area (BSA) of ≤3%
|
39.3 percentage of participants
|
21.8 percentage of participants
|
35.2 percentage of participants
|
43.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 16Population: mITT population included all participants who received at least one dose of study drug.
The NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.
Outcome measures
| Measure |
Placebo/Baricitinib 2-mg
n=117 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to placebo in the originating study (JAIW).
|
Baricitinib 1-mg/Baricitinib 2-mg
n=119 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg/Baricitinib 2-mg
n=108 Participants
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg Open-Label Addendum
n=30 Participants
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a ≥4-Point Improvement in Itch Numeric Rating Scale (NRS)
|
41.9 percentage of participants
|
29.4 percentage of participants
|
30.6 percentage of participants
|
26.7 percentage of participants
|
Adverse Events
Placebo/Baricitinib 2-mg
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
Baricitinib 1-mg/Baricitinib 2-mg
Serious events: 8 serious events
Other events: 22 other events
Deaths: 2 deaths
Baricitinib 2-mg/Baricitinib 2-mg
Serious events: 10 serious events
Other events: 28 other events
Deaths: 0 deaths
Baricitinib 2-mg Open-Label Addendum
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Baricitinib 2-mg
n=117 participants at risk
Open-label 2 mg baricitinib administered orally QD to participants who randomized to placebo in the originating study (JAIW).
|
Baricitinib 1-mg/Baricitinib 2-mg
n=119 participants at risk
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg/Baricitinib 2-mg
n=108 participants at risk
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg Open-Label Addendum
n=29 participants at risk
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.84%
1/119 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Cardiac disorders
Coronary artery dissection
|
0.85%
1/117 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
1.7%
2/119 • Number of events 2 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.84%
1/119 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.84%
1/119 • Number of events 2 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.85%
1/117 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.84%
1/119 • Number of events 2 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Graft infection
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Groin abscess
|
0.85%
1/117 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Peptic ulcer helicobacter
|
0.85%
1/117 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.84%
1/119 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Streptococcal abscess
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Wound infection
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.85%
1/117 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.84%
1/119 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.85%
1/117 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.85%
1/117 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous t-cell lymphoma stage iv
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.85%
1/117 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.84%
1/119 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Nervous system disorders
Loss of consciousness
|
0.85%
1/117 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.85%
1/117 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.84%
1/119 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Psychiatric disorders
Suicide attempt
|
0.85%
1/117 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.84%
1/119 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/108 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/117 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
Other adverse events
| Measure |
Placebo/Baricitinib 2-mg
n=117 participants at risk
Open-label 2 mg baricitinib administered orally QD to participants who randomized to placebo in the originating study (JAIW).
|
Baricitinib 1-mg/Baricitinib 2-mg
n=119 participants at risk
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 1 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg/Baricitinib 2-mg
n=108 participants at risk
Open-label 2 mg baricitinib administered orally QD to participants who randomized to 2 mg baricitinib in the originating study (JAIW).
|
Baricitinib 2-mg Open-Label Addendum
n=29 participants at risk
Participants were directly enrolled to receive open-label 2 mg baricitinib orally QD.
|
|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
7.7%
9/117 • Number of events 9 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
2.5%
3/119 • Number of events 3 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
4.6%
5/108 • Number of events 5 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
3.4%
1/29 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
10/117 • Number of events 14 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
7.6%
9/119 • Number of events 9 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
6.5%
7/108 • Number of events 7 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
12/117 • Number of events 13 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
6.7%
8/119 • Number of events 10 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
10.2%
11/108 • Number of events 15 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Infections and infestations
Urinary tract infection
|
6.0%
7/117 • Number of events 14 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
5.0%
6/119 • Number of events 6 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
6.5%
7/108 • Number of events 9 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
3.4%
1/29 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Nervous system disorders
Headache
|
6.8%
8/117 • Number of events 8 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/119 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.1%
6/117 • Number of events 6 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.84%
1/119 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.93%
1/108 • Number of events 1 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
0.00%
0/29 • Baseline to Follow-up (Up to 204 Weeks)
All participants who received at least one dose of study drug and who did not discontinue from the study for the reason "Lost to Follow-up" at the first postbaseline visit in study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60