Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (NCT NCT03570749)
NCT ID: NCT03570749
Last Updated: 2026-04-16
Results Overview
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
784 participants
Primary outcome timeframe
Week 36
Results posted on
2026-04-16
Participant Flow
The study was conducted in three separate parts with no participant overlap: • Phase 2 (Weeks 0-200): Participants completed 12 weeks of treatment or early discontinuation. At Week 12, an interim analysis was conducted to determine doses for Phase 3. Based on these Phase 2 interim results, subsequent participants in Phase 3 were enrolled and assigned to receive either baricitinib 2 mg or 4 mg.
* Phase 3 (Weeks 0-248): This phase 3 consisted of two treatment periods: Treatment Period 1 (Weeks 0-52) and Treatment Period 2 (Weeks 52-248), which included randomized withdrawal of baricitinib doses among responders and uptitration among baricitinib 2 mg nonresponders. * Phase 3 Open-Label Addendum (Weeks 0-52): An additional 20 Black or African American participants were enrolled in the United States to evaluate the effectiveness of baricitinib therapy.
Participant milestones
| Measure |
Placebo Phase 2
Participants received three placebo tablets administered orally once daily (QD). Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve Severity of Alopecia Tool (SALT) ≤20 (less than or equal to 20) during the study period.
|
1 Milligram (mg) / 4 mg Baricitinib Phase 2
Participants received one 1 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind through Week 12. Following the decision point at Week 12, participants were transitioned to receive one 4 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind, and continued treatment through Week 200.
|
2 mg Baricitinib Phase 2
Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 2
Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
|
Placebo Phase 3
Participants received two placebo tablets administered orally QD. Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve SALT≤20 during this treatment period.
|
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
Placebo/ Placebo Phase 3
Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
|
Placebo/ 2 mg Baricitinib Phase 3
Participants who received Placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
|
Placebo/ 4 mg Baricitinib Phase 3
Participants who received Placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
|
2 mg Baricitinib /2 mg Baricitinib Phase 3
Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.
|
2 mg Baricitinib /4 mg Baricitinib Phase 3
Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
|
2 mg Baricitinib / Placebo Phase 3
Participants who received 2 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
|
4 mg Baricitinib / Placebo Phase 3
Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
|
4 mg Baricitinib /4 mg Baricitinib Phase 3
Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
|
4 mg Baricitinib Phase 3 Open-Label Addendum
Participants who received one 4 mg Baricitinib tablet administered orally QD.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Period (Week 0 to Week 200)
STARTED
|
28
|
28
|
27
|
27
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period (Week 0 to Week 200)
Safety Population
|
28
|
28
|
27
|
27
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period (Week 0 to Week 200)
All Baricitinib Phase 2 (Combined Baricitinib: 1 mg/4 mg, 2 mg and 4 mg) -Safety Population
|
24
|
28
|
27
|
27
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
STARTED
|
0
|
0
|
0
|
0
|
189
|
184
|
281
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period (Week 0 to Week 200)
COMPLETED
|
10
|
11
|
15
|
16
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period (Week 0 to Week 200)
NOT COMPLETED
|
18
|
17
|
12
|
11
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Safety Population
|
0
|
0
|
0
|
0
|
189
|
183
|
280
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
All Baricitinib Phase 3 (Combined Baricitinib: 2 mg and 4 mg) - Safety Population
|
0
|
0
|
0
|
0
|
156
|
183
|
280
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
30
|
21
|
29
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
COMPLETED
|
0
|
0
|
0
|
0
|
159
|
163
|
252
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
76
|
73
|
32
|
121
|
10
|
109
|
143
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
27
|
37
|
20
|
60
|
7
|
29
|
96
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
49
|
36
|
12
|
61
|
3
|
80
|
47
|
0
|
|
Phase 3 Open Label Addendum (Week 0-52)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
|
Phase 3 Open Label Addendum (Week 0-52)
Safety Population
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
19
|
|
Phase 3 Open Label Addendum (Week 0-52)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Phase 3 Open Label Addendum (Week 0-52)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
Reasons for withdrawal
| Measure |
Placebo Phase 2
Participants received three placebo tablets administered orally once daily (QD). Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve Severity of Alopecia Tool (SALT) ≤20 (less than or equal to 20) during the study period.
|
1 Milligram (mg) / 4 mg Baricitinib Phase 2
Participants received one 1 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind through Week 12. Following the decision point at Week 12, participants were transitioned to receive one 4 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind, and continued treatment through Week 200.
|
2 mg Baricitinib Phase 2
Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 2
Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
|
Placebo Phase 3
Participants received two placebo tablets administered orally QD. Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve SALT≤20 during this treatment period.
|
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
Placebo/ Placebo Phase 3
Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
|
Placebo/ 2 mg Baricitinib Phase 3
Participants who received Placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
|
Placebo/ 4 mg Baricitinib Phase 3
Participants who received Placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
|
2 mg Baricitinib /2 mg Baricitinib Phase 3
Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.
|
2 mg Baricitinib /4 mg Baricitinib Phase 3
Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
|
2 mg Baricitinib / Placebo Phase 3
Participants who received 2 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
|
4 mg Baricitinib / Placebo Phase 3
Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
|
4 mg Baricitinib /4 mg Baricitinib Phase 3
Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
|
4 mg Baricitinib Phase 3 Open-Label Addendum
Participants who received one 4 mg Baricitinib tablet administered orally QD.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 Period (Week 0 to Week 200)
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period (Week 0 to Week 200)
Lack of Efficacy
|
1
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period (Week 0 to Week 200)
Lost to Follow-up
|
1
|
6
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period (Week 0 to Week 200)
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period (Week 0 to Week 200)
Withdrawal by Subject
|
8
|
5
|
6
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period (Week 0 to Week 200)
Protocol Defined Discontinuation Criteria Met at Week 76
|
7
|
4
|
2
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period (Week 0 to Week 200)
Did Not Meet Study Criteria; Out of range labs
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Period (Week 0 to Week 200)
Site procedural error; participant initiated commercial treatment
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
2
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
6
|
7
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Due to Pandemic
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
17
|
10
|
14
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Randomized, Not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Lack of Adherence
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Non-compliant with protocol
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 1 (Week 0 to Week 52)
Participant relocated and could not come to site visits
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
1
|
2
|
0
|
0
|
1
|
4
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
4
|
2
|
4
|
0
|
8
|
5
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
3
|
1
|
9
|
2
|
8
|
12
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Protocol Defined Discontinuation Criteria Met at Week 76
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
22
|
19
|
0
|
36
|
0
|
51
|
4
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
3
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
9
|
6
|
3
|
11
|
0
|
11
|
19
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Due to Pandemic
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Site Closed
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Protocol Deviation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Due to time constraints and inability to attend required study visits
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase 3 Period 2 (Week 52 to Week 248)
Met Exclusion criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Phase 3 Open Label Addendum (Week 0-52)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Phase 3 Open Label Addendum (Week 0-52)
Randomized but Not Treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase 3 Open Label Addendum (Week 0-52)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
Baseline Characteristics
The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the "4 mg Baricitinib Phase 3" arm, age data for one participant was not collected and therefore couldn't be reported (n=280).
Baseline characteristics by cohort
| Measure |
Placebo Phase 2
n=28 Participants
Participants received three placebo tablets administered orally every day (QD).
|
1 mg Baricitinib Phase 2
n=28 Participants
Participants received one 1 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
|
2 mg Baricitinib Phase 2
n=27 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 2
n=27 Participants
Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablet administered orally QD to maintain the blind.
|
Placebo Phase 3
n=189 Participants
Participants received two placebo tablets administered orally QD.
|
2 mg Baricitinib Phase 3
n=184 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=281 Participants
Participants received one 4 mg Baricitinib tablet administered orally, QD and one placebo tablet QD administered orally to maintain the blind.
|
4 mg Baricitinib Phase 3 Open-Label Addendum
n=20 Participants
Participants who received one 4 mg Baricitinib tablet administered orally QD.
|
Total
n=784 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Region of Enrollment
South Korea
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
70 Participants
n=189 Participants
|
70 Participants
n=184 Participants
|
107 Participants
n=281 Participants
|
0 Participants
n=20 Participants
|
247 Participants
n=784 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=28 Participants
|
25 Participants
n=28 Participants
|
24 Participants
n=27 Participants
|
24 Participants
n=27 Participants
|
103 Participants
n=189 Participants
|
102 Participants
n=184 Participants
|
153 Participants
n=281 Participants
|
20 Participants
n=20 Participants
|
476 Participants
n=784 Participants
|
|
Region of Enrollment
Japan
|
3 Participants
n=28 Participants
|
3 Participants
n=28 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=189 Participants
|
0 Participants
n=184 Participants
|
0 Participants
n=281 Participants
|
0 Participants
n=20 Participants
|
12 Participants
n=784 Participants
|
|
Region of Enrollment
Mexico
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
16 Participants
n=189 Participants
|
12 Participants
n=184 Participants
|
21 Participants
n=281 Participants
|
0 Participants
n=20 Participants
|
49 Participants
n=784 Participants
|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 14.23 • n=28 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the "4 mg Baricitinib Phase 3" arm, age data for one participant was not collected and therefore couldn't be reported (n=280).
|
38.6 years
STANDARD_DEVIATION 11.26 • n=28 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the "4 mg Baricitinib Phase 3" arm, age data for one participant was not collected and therefore couldn't be reported (n=280).
|
42.5 years
STANDARD_DEVIATION 13.75 • n=27 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the "4 mg Baricitinib Phase 3" arm, age data for one participant was not collected and therefore couldn't be reported (n=280).
|
42.4 years
STANDARD_DEVIATION 14.91 • n=27 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the "4 mg Baricitinib Phase 3" arm, age data for one participant was not collected and therefore couldn't be reported (n=280).
|
37.4 years
STANDARD_DEVIATION 12.91 • n=189 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the "4 mg Baricitinib Phase 3" arm, age data for one participant was not collected and therefore couldn't be reported (n=280).
|
38.0 years
STANDARD_DEVIATION 12.78 • n=184 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the "4 mg Baricitinib Phase 3" arm, age data for one participant was not collected and therefore couldn't be reported (n=280).
|
36.3 years
STANDARD_DEVIATION 13.27 • n=280 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the "4 mg Baricitinib Phase 3" arm, age data for one participant was not collected and therefore couldn't be reported (n=280).
|
46.0 years
STANDARD_DEVIATION 8.75 • n=20 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the "4 mg Baricitinib Phase 3" arm, age data for one participant was not collected and therefore couldn't be reported (n=280).
|
37.8 years
STANDARD_DEVIATION 13.0 • n=783 Participants • The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the "4 mg Baricitinib Phase 3" arm, age data for one participant was not collected and therefore couldn't be reported (n=280).
|
|
Sex: Female, Male
Female
|
16 Participants
n=28 Participants
|
18 Participants
n=28 Participants
|
23 Participants
n=27 Participants
|
25 Participants
n=27 Participants
|
109 Participants
n=189 Participants
|
109 Participants
n=184 Participants
|
165 Participants
n=281 Participants
|
15 Participants
n=20 Participants
|
480 Participants
n=784 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=28 Participants
|
10 Participants
n=28 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=27 Participants
|
80 Participants
n=189 Participants
|
75 Participants
n=184 Participants
|
116 Participants
n=281 Participants
|
5 Participants
n=20 Participants
|
304 Participants
n=784 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=27 Participants
|
8 Participants
n=189 Participants
|
5 Participants
n=184 Participants
|
8 Participants
n=281 Participants
|
0 Participants
n=20 Participants
|
22 Participants
n=784 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=28 Participants
|
4 Participants
n=28 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=27 Participants
|
78 Participants
n=189 Participants
|
76 Participants
n=184 Participants
|
114 Participants
n=281 Participants
|
0 Participants
n=20 Participants
|
282 Participants
n=784 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=189 Participants
|
1 Participants
n=184 Participants
|
1 Participants
n=281 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=784 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=28 Participants
|
2 Participants
n=28 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=27 Participants
|
17 Participants
n=189 Participants
|
7 Participants
n=184 Participants
|
28 Participants
n=281 Participants
|
19 Participants
n=20 Participants
|
83 Participants
n=784 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=28 Participants
|
22 Participants
n=28 Participants
|
20 Participants
n=27 Participants
|
19 Participants
n=27 Participants
|
83 Participants
n=189 Participants
|
93 Participants
n=184 Participants
|
123 Participants
n=281 Participants
|
0 Participants
n=20 Participants
|
381 Participants
n=784 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=189 Participants
|
1 Participants
n=184 Participants
|
6 Participants
n=281 Participants
|
1 Participants
n=20 Participants
|
9 Participants
n=784 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=189 Participants
|
1 Participants
n=184 Participants
|
1 Participants
n=281 Participants
|
0 Participants
n=20 Participants
|
4 Participants
n=784 Participants
|
|
Baseline Disease Severity of Alopecia Tool (SALT) Score
|
90.0 units on a scale
STANDARD_DEVIATION 15.69 • n=28 Participants
|
89.3 units on a scale
STANDARD_DEVIATION 17.65 • n=28 Participants
|
86.1 units on a scale
STANDARD_DEVIATION 19.32 • n=27 Participants
|
83.4 units on a scale
STANDARD_DEVIATION 17.52 • n=27 Participants
|
84.7 units on a scale
STANDARD_DEVIATION 17.82 • n=189 Participants
|
86.8 units on a scale
STANDARD_DEVIATION 18.01 • n=184 Participants
|
85.3 units on a scale
STANDARD_DEVIATION 18.18 • n=281 Participants
|
79.1 units on a scale
STANDARD_DEVIATION 21.28 • n=20 Participants
|
85.6 units on a scale
STANDARD_DEVIATION 17.5 • n=784 Participants
|
PRIMARY outcome
Timeframe: Week 36Population: All randomized phase 3 participants who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
Outcome measures
| Measure |
Placebo Phase 3
n=189 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
n=184 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=281 Participants
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3
|
5.3 percentage of participants
Interval 2.9 to 9.5
|
21.7 percentage of participants
Interval 16.4 to 28.2
|
35.2 percentage of participants
Interval 29.9 to 41.0
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: All randomized phase 3 open-label addendum participants who had evaluable data for this outcome measure.
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes.
Outcome measures
| Measure |
Placebo Phase 3
n=11 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percent Change From Baseline in SALT Score - Phase 3 Open-Label Addendum
|
-40.44 percent change
Standard Deviation 33.182
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: All randomized phase 3 participants with non-missing baseline and at least one post-baseline measurement who had evaluable data for this outcome measure.A modified last observation carried forward (mLOCF) imputation technique was used to replace missing data with the most recent non-missing post-baseline assessment.
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (\< 4 years versus ≥4 years), treatment group, and baseline value in the model.
Outcome measures
| Measure |
Placebo Phase 3
n=185 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
n=180 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=278 Participants
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percent Change From Baseline in SALT Score - Phase 3
|
-8.13 percent change
Standard Error 3.100
|
-31.23 percent change
Standard Error 3.157
|
-45.79 percent change
Standard Error 2.663
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized phase 3 participants who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process . The SALT score will range from 0% to 100%. with lower score indicating better health outcomes.
Outcome measures
| Measure |
Placebo Phase 3
n=189 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
n=184 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=281 Participants
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3
|
4.8 percentage of participants
Interval 2.5 to 8.8
|
9.8 percentage of participants
Interval 6.3 to 14.9
|
21.7 percentage of participants
Interval 17.3 to 26.9
|
SECONDARY outcome
Timeframe: Week 36Population: All randomized phase 3 participants who had evaluable data for this outcome measure.
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Kaplan-Meier method was used for analysis. Time for participants to achieve salt ≤ 20 at week 36 were reported in this outcome measure.
Outcome measures
| Measure |
Placebo Phase 3
n=189 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
n=184 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=281 Participants
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Time for Participants to Achieve SALT ≤ 20 at Week 36 - Phase 3
|
NA Days
Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.
|
NA Days
Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.
|
NA Days
Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Week 36Population: All randomized phase 3 participants with baseline ClinRO measure for EB Hair Loss ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.
Outcome measures
| Measure |
Placebo Phase 3
n=124 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
n=136 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=188 Participants
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving Clinician Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥ 2 at Baseline) - Phase 3
|
3.2 percentage of participants
Interval 1.3 to 8.0
|
19.1 percentage of participants
Interval 13.4 to 26.5
|
31.4 percentage of participants
Interval 25.2 to 38.3
|
SECONDARY outcome
Timeframe: Week 36Population: All randomized phase 3 participants with baseline ClinRO measure for EL hair loss ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.
Outcome measures
| Measure |
Placebo Phase 3
n=96 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
n=111 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=167 Participants
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3
|
3.1 percentage of participants
Interval 1.1 to 8.8
|
13.5 percentage of participants
Interval 8.4 to 21.1
|
33.5 percentage of participants
Interval 26.8 to 41.0
|
SECONDARY outcome
Timeframe: Week 36Population: All randomized phase 3 participants with baseline PRO for scalp hair assessment of ≥ 3 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
PRO is an assessment of the participant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).
Outcome measures
| Measure |
Placebo Phase 3
n=181 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
n=175 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=275 Participants
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants With Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥ 2 Point Improvement From Baseline Among Participants With a Score of ≥ 3 at Baseline - Phase 3
|
5.0 percentage of participants
Interval 2.6 to 9.2
|
16.0 percentage of participants
Interval 11.3 to 22.2
|
33.1 percentage of participants
Interval 27.8 to 38.9
|
SECONDARY outcome
Timeframe: Week 36Population: All randomized phase 3 participants with baseline PRO measure for EB ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs.
Outcome measures
| Measure |
Placebo Phase 3
n=130 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
n=141 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=184 Participants
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving PRO Measure for EB 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥ 2 at Baseline) - Phase 3
|
3.1 percentage of participants
Interval 1.2 to 7.6
|
16.3 percentage of participants
Interval 11.1 to 23.3
|
32.1 percentage of participants
Interval 25.7 to 39.1
|
SECONDARY outcome
Timeframe: Week 36Population: All randomized phase 3 participants with baseline with baseline PRO measure for EL ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair.
Outcome measures
| Measure |
Placebo Phase 3
n=100 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
n=112 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=161 Participants
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥2 at Baseline) - Phase 3
|
2.0 percentage of participants
Interval 0.6 to 7.0
|
19.6 percentage of participants
Interval 13.3 to 28.0
|
29.8 percentage of participants
Interval 23.3 to 37.3
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: All randomized phase 3 participants with non-missing baseline and at least one post-baseline measurement who had evaluable data for this outcome measure. The method used to handle missing data will be mLOCF which used the most recent nonmissing postbaseline assessment.
The Hospital Anxiety Depression Scale (HADS) is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.
Outcome measures
| Measure |
Placebo Phase 3
n=177 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
n=174 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=272 Participants
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3
|
-0.40 score on a scale
Standard Error 0.234
|
-1.22 score on a scale
Standard Error 0.236
|
-0.93 score on a scale
Standard Error 0.199
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: All randomized phase 3 participants with non-missing baseline and at least one post-baseline measurement who had evaluable data for this outcome measure. The method used to handle missing data will be mLOCF which used the most recent nonmissing postbaseline assessment.
The HADS is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression. LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (\<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.
Outcome measures
| Measure |
Placebo Phase 3
n=177 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
n=174 Participants
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
n=272 Participants
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Mean Change From Baseline in HADS Depression Score - Phase 3
|
0.04 score on a scale
Standard Error 0.210
|
-0.38 score on a scale
Standard Error 0.213
|
-0.28 score on a scale
Standard Error 0.179
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized phase 3 open-label addendum participants who had evaluable data for this outcome measure.
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
Outcome measures
| Measure |
Placebo Phase 3
n=11 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving SALT ≤ 20 - Phase 3 Open-Label Addendum
|
18.2 percentage of participants
Interval 5.1 to 47.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized phase 3 open-label addendum participants who had evaluable data for this outcome measure.
SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process . The SALT score will range from 0% to 100%. with lower score indicating better health outcomes.
Outcome measures
| Measure |
Placebo Phase 3
n=11 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 Open-Label Addendum
|
45.5 percentage of participants
Interval 21.3 to 72.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized phase 3 open-label addendum participants with baseline ClinRO measure for EB Hair Loss ≥ 2 and who had evaluable data for this outcome measure.
ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.
Outcome measures
| Measure |
Placebo Phase 3
n=4 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving ClinRO Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥ 2 at Baseline) - Phase 3 Open-Label Addendum
|
50.0 percentage of participants
Interval 15.0 to 85.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized phase 3 open-label addendum participants with baseline ClinRO measure for EL hair loss ≥ 2 and who had evaluable data for this outcome measure.
ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.
Outcome measures
| Measure |
Placebo Phase 3
n=3 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3 Open-Label Addendum
|
66.7 percentage of participants
Interval 20.8 to 93.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: All randomized phase 3 open-label addendum participants with baseline PRO for scalp hair assessment of ≥ 3 and who had evaluable data for this outcome measure.
PRO is an assessment of the participant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).
Outcome measures
| Measure |
Placebo Phase 3
n=10 Participants
Participants received two placebo tablets administered orally every day (QD).
|
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
|
|---|---|---|---|
|
Percentage of Participants With Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥ 2 Point Improvement From Baseline Among Participants With a Score of ≥ 3 at Baseline - Phase 3 Open-Label Addendum
|
20.0 percentage of participants
Interval 5.7 to 51.0
|
—
|
—
|
Adverse Events
Placebo Phase 2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
2 mg Baricitinib Phase 2
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
4 mg Baricitinib Phase 2
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
All Baricitinib Phase 2 (Combined Baricitinib: 1 mg/4 mg, 2 mg and 4 mg)
Serious events: 3 serious events
Other events: 79 other events
Deaths: 0 deaths
Placebo Phase 3
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
2 mg Baricitinib Phase 3
Serious events: 7 serious events
Other events: 58 other events
Deaths: 0 deaths
4 mg Baricitinib Phase 3
Serious events: 16 serious events
Other events: 126 other events
Deaths: 0 deaths
All Baricitinib Phase 3 (Combined Baricitinib: 2 mg and 4 mg)
Serious events: 40 serious events
Other events: 275 other events
Deaths: 0 deaths
4 mg Baricitinib Phase 3 Open-Label Addendum
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Phase 2
n=28 participants at risk
\- Week 0 to Week 200: Participants received three placebo tablets administered orally QD.
|
2 mg Baricitinib Phase 2
n=27 participants at risk
\- Week 0 to Week 200: Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 2
n=27 participants at risk
\- Week 0 to Week 200: Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
|
All Baricitinib Phase 2 (Combined Baricitinib: 1 mg/4 mg, 2 mg and 4 mg)
n=106 participants at risk
Participants who received Baricitinib in any of the three treatment arms \[1 mg/4 mg arm (1 mg until Week 12, then 4 mg until Week 200), 2 mg arm, or 4 mg arm\], plus Placebo participants who were rescued to Baricitinib at any time during the treatment period (Week 0 to Week 200) of Phase 2 were grouped in this arm.
|
Placebo Phase 3
n=189 participants at risk
* Week 0 to Week 52: Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind (Period 1).
* Week 52 to Week 248: Participants continued to receive the same placebo or switched to either 2 mg or 4 mg Baricitinib dose administered orally QD (Period 2).
|
2 mg Baricitinib Phase 3
n=183 participants at risk
* Week 0 to Week 52: Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind (Period 1).
* Week 52 to Week 248: Participants continued to receive the same 2 mg dose or switched to an uptitrated 4 mg Baricitinib dose administered orally QD (Period 2).
|
4 mg Baricitinib Phase 3
n=280 participants at risk
* Week 0 to Week 52: Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind (Period 1).
* Week 52 to Week 248: Participants continued to receive the same 4 mg dose or switched to a downtitrated 2 mg Baricitinib dose, or receive placebo tablets matched to Baricitinib administered orally QD (Period 2).
|
All Baricitinib Phase 3 (Combined Baricitinib: 2 mg and 4 mg)
n=619 participants at risk
Participants who received Baricitinib in any of 2 mg arm or the 4 mg arm, plus Placebo participants who were rescued to Baricitinib at any time during the treatment period (Week 0 to Week 248) of Phase 3 were grouped in this arm.
|
4 mg Baricitinib Phase 3 Open-Label Addendum
n=19 participants at risk
Week 0 to Week 52: Participants who received one 4 mg Baricitinib tablet administered orally QD.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/183 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/183 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Cyst
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.94%
1/106 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
2/280 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
2/619 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
2/619 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Varicella
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Anastomotic ulcer
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Ankle fracture
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/183 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
2/619 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Clavicle fracture
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Craniofacial fracture
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.71%
2/280 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
2/619 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Foot fracture
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/183 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
2/619 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Hand fracture
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/183 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
2/619 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Humerus fracture
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.53%
1/189 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Ligament sprain
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
2/619 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Radius fracture
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/183 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Rhabdomyolysis
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.53%
1/189 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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)
Chronic lymphocytic leukaemia
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.36%
1/280 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Stiff person syndrome
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/16 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/81 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/109 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/108 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.61%
1/164 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.28%
1/360 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/14 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.53%
1/189 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Acute respiratory failure
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Pulmonary embolism
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.55%
1/183 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.32%
2/619 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Sleeve gastrectomy
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.16%
1/619 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.94%
1/106 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Thermal burn
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.94%
1/106 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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 dysplasia
|
0.00%
0/16 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/81 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/109 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/108 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/164 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/360 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/14 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Priapism
|
0.00%
0/12 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/4 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/80 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/75 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/116 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/259 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
Placebo Phase 2
n=28 participants at risk
\- Week 0 to Week 200: Participants received three placebo tablets administered orally QD.
|
2 mg Baricitinib Phase 2
n=27 participants at risk
\- Week 0 to Week 200: Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
|
4 mg Baricitinib Phase 2
n=27 participants at risk
\- Week 0 to Week 200: Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
|
All Baricitinib Phase 2 (Combined Baricitinib: 1 mg/4 mg, 2 mg and 4 mg)
n=106 participants at risk
Participants who received Baricitinib in any of the three treatment arms \[1 mg/4 mg arm (1 mg until Week 12, then 4 mg until Week 200), 2 mg arm, or 4 mg arm\], plus Placebo participants who were rescued to Baricitinib at any time during the treatment period (Week 0 to Week 200) of Phase 2 were grouped in this arm.
|
Placebo Phase 3
n=189 participants at risk
* Week 0 to Week 52: Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind (Period 1).
* Week 52 to Week 248: Participants continued to receive the same placebo or switched to either 2 mg or 4 mg Baricitinib dose administered orally QD (Period 2).
|
2 mg Baricitinib Phase 3
n=183 participants at risk
* Week 0 to Week 52: Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind (Period 1).
* Week 52 to Week 248: Participants continued to receive the same 2 mg dose or switched to an uptitrated 4 mg Baricitinib dose administered orally QD (Period 2).
|
4 mg Baricitinib Phase 3
n=280 participants at risk
* Week 0 to Week 52: Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind (Period 1).
* Week 52 to Week 248: Participants continued to receive the same 4 mg dose or switched to a downtitrated 2 mg Baricitinib dose, or receive placebo tablets matched to Baricitinib administered orally QD (Period 2).
|
All Baricitinib Phase 3 (Combined Baricitinib: 2 mg and 4 mg)
n=619 participants at risk
Participants who received Baricitinib in any of 2 mg arm or the 4 mg arm, plus Placebo participants who were rescued to Baricitinib at any time during the treatment period (Week 0 to Week 248) of Phase 3 were grouped in this arm.
|
4 mg Baricitinib Phase 3 Open-Label Addendum
n=19 participants at risk
Week 0 to Week 52: Participants who received one 4 mg Baricitinib tablet administered orally QD.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.2%
15/106 • Number of events 16 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
3/189 • Number of events 4 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.8%
18/183 • Number of events 18 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
16.4%
46/280 • Number of events 50 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.0%
130/619 • Number of events 139 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
4/106 • Number of events 4 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
3/189 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
3/183 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.4%
15/280 • Number of events 20 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
20/619 • Number of events 25 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
1/28 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
14.8%
4/27 • Number of events 6 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
13.2%
14/106 • Number of events 17 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.3%
12/189 • Number of events 13 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
13/183 • Number of events 15 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
28/280 • Number of events 36 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.8%
48/619 • Number of events 62 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
|
17.9%
5/28 • Number of events 8 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
29.6%
8/27 • Number of events 8 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
29.6%
8/27 • Number of events 8 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
30.2%
32/106 • Number of events 38 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
10/189 • Number of events 17 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
9.3%
17/183 • Number of events 24 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
28/280 • Number of events 47 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.2%
63/619 • Number of events 99 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.8%
3/19 • Number of events 4 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
|
3.6%
1/28 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
6/106 • Number of events 7 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.1%
4/189 • Number of events 8 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.3%
6/183 • Number of events 7 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
16/280 • Number of events 21 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
30/619 • Number of events 46 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
15.8%
3/19 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.1%
2/189 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.2%
4/183 • Number of events 4 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.4%
29/280 • Number of events 47 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.8%
42/619 • Number of events 64 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.8%
9/189 • Number of events 13 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.6%
12/183 • Number of events 12 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
20/280 • Number of events 37 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.1%
38/619 • Number of events 58 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Acne
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
3/27 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.5%
8/106 • Number of events 10 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.53%
1/189 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.1%
13/183 • Number of events 13 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.8%
19/280 • Number of events 21 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.9%
49/619 • Number of events 52 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
21.1%
4/19 • Number of events 4 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Neutropenia
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
3/27 • Number of events 4 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.6%
7/106 • Number of events 9 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.5%
2/19 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
3/27 • Number of events 4 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.5%
8/106 • Number of events 9 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
3/106 • Number of events 4 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.5%
8/106 • Number of events 8 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
3.6%
1/28 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
3/27 • Number of events 4 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
6/106 • Number of events 16 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
6/106 • Number of events 6 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
6.2%
1/16 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.2%
1/81 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/109 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/108 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/164 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/360 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/14 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.6%
1/28 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.8%
3/106 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
|
7.1%
2/28 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
3/27 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
6/106 • Number of events 6 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
|
10.7%
3/28 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
3/27 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
4/106 • Number of events 4 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.7%
5/106 • Number of events 5 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
3.6%
1/28 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
3/27 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.7%
6/106 • Number of events 6 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Endometriosis
|
6.2%
1/16 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/23 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/25 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/81 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/109 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/108 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/164 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/360 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/14 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Dermatitis contact
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
11.1%
3/27 • Number of events 3 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.5%
9/106 • Number of events 9 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
|
3.6%
1/28 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.9%
2/106 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Urticaria
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
7.4%
2/27 • Number of events 2 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.7%
1/27 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.8%
4/106 • Number of events 5 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/19 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Paronychia
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Ankle fracture
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Pain in extremity
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Obstructive sleep apnoea syndrome
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Oropharyngeal pain
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Upper-airway cough syndrome
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Blister
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Eczema
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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
Skin discolouration
|
0.00%
0/28 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/27 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/106 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/189 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/183 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/280 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/619 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. 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